Structure and Function: Key Criteria in Evaluating Description Requirements for Harmonization of the US and European Patent Systems

E. Bruno and C. Tunstall


When pursuing patent protections in both the US and Europe (EPO), users experience tensions between the two systems which complicate the related drafting and prosecution processes.

These tensions are due to the fact that standards and criteria to evaluate patentability in the US law[1] and EPC are not only different, but also very often subjective and rooted in the local practice and, therefore, are difficult to understand for a practitioner from a different jurisdiction.

The above situation leaves an applicant from a different jurisdiction in dismay, escalated because the tension arises when it is too late to modify the description to include additional information. Therefore, the applicant is often left the impossibility to pursue intended embodiments without an understandable explanation as the requested information often stems from a subjective evaluation performed from the point of view of a different patent practice.

Some commentators suggest that these tensions are inevitable due to the intrinsic differences between the two patent systems.[2] However, both the US and EPC patent systems already include criteria that are both objective and objectively verifiable and that apply to all embodiments and aspects of an invention independently from the technology, that are consistent between the systems, and that provide direct reference to elements of the description and claims.

In particular, structure, function, and the correlation between the two are criteria that are used in the US and EP patent systems to evaluate support, clarity and added matter and that also provide the core for evaluating novelty and obviousness/inventive steps of an invention.

In a world where the five major patent offices have been spending significant efforts and resources to harmonize different patent systems[3], a further development of the existing guidelines using those criteria would be, therefore, highly desirable as it would allow users of different jurisdictions to better understand what is required when drafting and prosecuting patent applications directed to international protection.

Structure and function in the form of "identifying characteristics" are criteria for evaluation of written description requirement and added matter in the US

The US written description requirement requires that the patent applicant is in full possession of the claimed subject matter on the application filing date.[4]

The standard to evaluate written description in the claims is "whether the specification conveys with reasonable clarity... [that] applicant was in possession of the invention as now claimed."[5]

This standard is also applied when one evaluates whether an amendment of the claims violates the prohibition against added matter according to US patent law[6] (according to US patent law, prohibition against added matter in the specification and prohibition against added matter in the claims have different legal bases.[7])

The "convey possession" standard, however, is highly subjective as, in absence of specific criteria, the related application to a specific fact pattern highly depends on the point of view of the person performing the analysis.

Various criteria are used to determine whether the specification conveys possession of the invention as claimed, the criteria being a non-exhaustive list of items all making reference to specific elements of the specification.

"Identifying characteristics" is among those criteria, and refers to complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.[8]

Identifying characteristics are, in particular, applied in Step 3 of the methodology below used to determine compliance of the claims with 35 USC 112(a) "written description"[9]:

  1. Determine what claim as a whole covers;
  2. Review the entire application to understand support including each element and / or step;
  3. Determine whether there is sufficient written description to inform a skilled artisan that the applicant was in possession of the claimed invention as a whole at the time the application was filed.

As an explanation of "identifying characteristics" by example:

"If the application ... does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine ... other relevant identifying characteristics...

For example, if ... strong correlation between structure and function, one skilled in the art would be able to predict ... the structure of the claimed invention from a recitation of its function"[10]

The above criteria have been confirmed by the Federal Circuit in its decision Amgen v. Sanofi decision[11], in which the Court rejected the so called "newly characterized antigen test". In so doing the Court stated that

Both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies. Because the scientific premise behind the "newly characterized antigen" test stated in the instruction in this case was neither "generally known" nor "accurately and readily" ascertainable, we cannot take judicial notice of the premise and displace the required fact finding with what amounts to a rule of law."[12],

thus confirming the 'identifying characteristics" as reference criteria for written description analysis in the US.

Therefore, due to an internal harmonization of the requirements for support required at and after filing in the US system, the criteria of structure, function, and their correlation allow a user to evaluate if a given embodiment is described adequately enough to be pursued in the application both at the time of and after the time of filing.

Accordingly, in the US, "identifying characteristics", if correctly applied in accordance with MPEP, would:

  • minimise added matter issues as the added matter is a corollary of written description[13];
  • apply to all the embodiments/aspects of the invention - virtually all inventions can be described as variants/properties or uses;
  • be objective and objectively verifiable during prosecution (differently from, for example, "convey possession" which is a subjective standard).

The "identifying characteristics" are also consistent with corresponding criteria in different jurisdictions and in particular before the EPO to a certain extent as it will be shown in the following sections.

Structure and function in the form of "variants and related properties and uses" are criteria to evaluate support under Article 84 EPC

In the EP system, the requirement of support in the description has a legal basis in Art 84 EPC which indicates that "the claims shall ...be clear and concise and be supported by the description."

The EPO guidelines provide criteria to evaluate compliance of a description with the requirement of Art. 84 EPC. In particular, in the Guidelines[14], it is stated that

"Most claims are generalizations from one or more particular examples. ... The applicant should be allowed to cover all obvious modifications of, equivalents to and uses of that which he has described. In particular, if it is reasonable to predict that all the variants covered by the claims have the properties or uses the applicant ascribes to them in the description, he should be allowed to draw his claims accordingly."[15]

Thus, description of variants covered by the claims and related properties or uses in accordance with EPO Guidelines does:

  • Minimise added matter issues in connection with generalisation at least to a certain extent since after filing Art 123(2) EPC prevails (see however discussion of added matter below);
  • Apply to all the embodiments/aspects of the invention - virtually all inventions can be described as variants/properties or uses
  • Be objective and objectively verifiable during prosecution - to a certain extent since what is a "variant" can be subjective
  • Be consistent with criteria of different jurisdictions and in particular the US system at least to a certain extent.

In particular, the EPO variant criteria provide strong parallels with the corresponding criteria used to evaluate support in the US system, as will be evident from the following side-by-side comparison.

  • EPO: if it is reasonable to predict that all the variants covered by the claims have the properties or uses the applicant ascribes to them in the description, [then] he should be allowed to draw his claims accordingly.[16]
  • US: if [there is] strong correlation between structure and function, one skilled in the art would be able to predict ... the structure of the claimed invention from a recitation of its function."[17]

Therefore, EPO variants covered by the claims and related properties or uses provide an EPO version of the US identifying characteristics.

The US structure and function, however, appear preferable for users because they are more objective and are easily recognisable, verifiable, and portable between different types of inventions, as well as different aspects of one invention.

A further elaboration of the "variants and related properties or uses" (referring to structure/function of the variants) would help users (in particular US users) draft applications in a way that will smoothen prosecution.

Such an elaboration would also allow, as will be shown herein, a better interplay with the evaluation of the clarity requirement under Article 84 EPC and the added matter requirement under Article 123(2) EPC (which is also performed, at least to a certain extent, using structure, function and related relationship as evaluating criteria as more extensively discussed below).

Structure and function are criteria to evaluate clarity under Article 84 EPC

The clarity predictability requirement of Article 84 EPC is barely discussed in the EPO Guidelines. The case law of the EPO Boards of Appeal, however, provides criteria which makes direct reference to elements of the description and claims and, in particular, to structural and functional features of the invention as described/claimed.

The book "Case Law of the EPO Boards of Appeal"[18] indicates that, in case T 361/88, the board distinguished between two types of functional features:

"the first type of functional feature is related to process steps which are known ...and may easily be performed in order to obtain the desired result;

the second type of functional feature consists of process steps defined by the result which is aimed at. This is also allowable as long as the man skilled in the art knows, without exceeding his normal skills and knowledge, what he has to do in order to obtain said result."[19]

Additional EPO case law on clarity/predictability under Article 84 EPC makes reference to structure/function:

T68/85: "8.4.3 On the other hand, the effort to define a feature in functional terms must stop short where it jeopardises the clarity of a claim as required by Article 84 EPC... [demanding] not only that a skilled person be able to understand the teaching of the claim but also that he be able to implement it.

In other words, the feature must provide instructions which are sufficiently clear for the expert to reduce them to practice without undue burden, if necessary with reasonable experiments" (on the predictability requirement of Article 84 EPC - Clarity).

EPO case law on the clarity/predictability requirement of Article 84 EPC makes reference to structure/functions:

T720/92: "3.1.3 ... (v) ... The person skilled in the art should ...understand what is meant by the language of a claim without ambiguity and without complicated, time-consuming investigations, i.e. without undue burden.

This applies also to functional features, i.e. features which become manifest only on exposure to qualifying conditions ...; the acknowledgement of their clarity depends on the amount of verifying input necessary to conclude whether or not a functional parameter is met."

EPO case law on the clarity /predictability requirement of Article 84 EPC makes reference to structure/ function:

T720/92 (continued): In areas where experimentation is required, clarity can ... be recognised only if with usual methods or methods disclosed in the application, possibly together with common general knowledge, the skilled person is in a position to purposefully design embodiments of the invention by routine experimentation.

That is, clarity cannot be recognised if verification of a functional feature involves the working out of experimental activities or even strategies which are not disclosed in the application and are not within common general knowledge, thus imposing on the expert an undue burden."

In determining the clarity of functional features, the importance of the ability of the skilled person to purposefully choose the right structure and the right values for parameters has long been recognized:

T0361/88: "3.2.2. As regards the features 'extended slowly and at low tension', it is considered that the man skilled in the art, ... is able... to choose the right values for the extension speed and the tension dependent on the other parameters of the process and adapted to the filaments treated, to obtain the result aimed at."

If choosing the right structure and selecting the appropriate values for parameters presents the skilled person with an undue burden, then clarity is not acknowledged:

T0754/13: "2.3.9 ... According to the jurisprudence the skilled person must be in a position to ascertain where the boundaries of the scope of claim 1 are and not only to verify whether or not he is infringing the process of claim 1. In the present case he does not know these boundaries from the definitions of claim 1 and to determine the same he is confronted with a small research program, which is an undue burden, as considered by the Board."

A synthesis of these Article 84 cases on the clarity/predictability requirement leads to the conclusion that a functional feature (a feature which becomes manifest only on exposure to qualifying conditions) is clear if the skilled person - is able, without undue burden, to select the right structure or - choose the right values for parameters so that the function will be achieved under those qualifying conditions.

In other words, the functional feature is clear if it is possible to predict with reasonable effort which of the structural and parametric variants allowed by the claim also give rise to the functional requirements of the claim.

There are similarities between the assessment of support and clarity under Article 84:

  • EPO Guidelines on Support (Art. 84): In particular, if it is reasonable to predict that all the variants covered by the claims have the properties or uses the applicant ascribes to them in the description, he should be allowed to draw his claims accordingly.
  • EPO case law on Clarity (Art. 84): If it is possible to predict with reasonable effort which of the structural and parametric variants allowed by the claim also give rise to the functional requirements of the claim, the functional feature is clear (and the applicant should be allowed to draw his claims accordingly).

Therefore, structural and parametric variants related features or combination of features and related functional properties:

  • provide criteria in EPO case law to evaluate the Predictability Requirement of clarity of Art. 84 EPC, which
  • make direct reference to elements of the description/ claims, and
  • have similarities to criteria for the Support Requirement of Art. 84 EPC, i.e. "all the variants covered by the claims have the properties or uses the applicant ascribes to them in the description"

Guidelines (with respect to clarity/predictability) could be drawn to:

  • indicate that it must be possible to predict which of the structural and parametric variants allowed by the claim also have the functional properties of the claim[20] (see T720/92),
  • complement the Guidelines concerning the Support requirement indicating that
  • indicate that it must be reasonable to predict that all the variants covered by the claims have the properties or uses the applicant ascribes to them.[21]

An introduction of those guidelines, which are based on EPO case law, would guide users to draft applications in a way that would:

  • apply to all the embodiments/aspects of the invention - as they refer to variants and related features / properties and uses, and
  • be objective and objectively verifiable during prosecution - in view of direct reference to features and properties /uses.

Structure and function are criteria to evaluate added matter under Article 123(2) EPC

The "gold standard" before the EPO for evaluating added matter is: "if the overall change in ...content...results in .. information which is not directly and unambiguously derivable from ...the application, even when account is taken of matter which is implicit to a person skilled in the art"[22]

However, whether or not a specific subject matter can be derived "directly and unambiguously" from a specific description is a conclusion in the eye of the beholder, and different conclusions are reached by different examiners performing the analysis.

The criteria used for the general application of the "gold standard" are based on i) general reference to "information" presented in the application and ii) "implicit disclosure"[23], with very narrow applicability of iii) common knowledge[24]. No reference is made under the "gold standard" to specific elements of the description.

Reference to specific elements of the description can be found only in examples provided in and specific case law cited by the Guidelines. For example: replacement/removal of a feature (H-V.3.1), additional features (H-V.3.2), intermediate generalizations (H-V.3.2.1), deletion of part of the claimed subject-matter (H-V.3.3), disclosed disclaimer (H-V.3.5). The EPO standard to evaluate added matter makes no reference to specific elements of the specification unless the evaluation is performed in connection with specific fact patterns.

The absence of a direct connection of the general EP criteria for added matter to specific elements of the description makes the related application arguable, subjective and open to interpretation unless the analysis is performed in connection with the specific fact patterns of the provided examples and case law.

Take, for example, case G1/93 (EPO). In this case, the Board remarked:

"Whether or not the adding of an undisclosed feature limiting the scope of protection conferred by the patent as granted would be contrary to the purpose of Article 123(2) EPC ... depends on the circumstances.

If such added feature, although limiting the scope of protection conferred by the patent, has to be considered as providing a technical contribution to the subject-matter of the claimed invention, it would, in the view of the Enlarged Board, give an unwarranted advantage to the patentee contrary to the above purpose of Article 123(2) EPC.

Consequently, such feature would constitute added subject-matter in the sense of that provision. ...

If, on the other hand, the feature in question merely excludes protection for part of the subject-matter of the claimed invention as covered by the application as filed, the adding of such feature cannot reasonably be considered to give any unwarranted advantage to the applicant."[25]

An integration of the EPO Guidelines along this line, providing general criteria for evaluation of the effect of undisclosed added feature with indications making specific reference to elements of the description, would make the analysis more objective. The tests set forth in the examples and case law already provide those indications.

However, an effort could be made to use them in a more general test, complementing the specific tests already in existence. Such a general test would provide valuable guidance for drafters and examiners for all those situations where the specific tests are not applicable, or when the applicability of the tests for specific fact patterns is arguable (e.g., an amendment resulting in the addition of one or more features and the removal of one or more features). Such a test would also provide an important tool for harmonization if it is formulated with criteria that have elements in common with the US system.

One already existing test, using "structure and function" as reference criteria, is the test for intermediate generalization. In fact patterns where generalization is sought, extracting a specific feature may be allowed "only if there is no structural and functional relationship between the features."[26], and replacing or removing of a feature from a claim does not violate Article 123(2) if the skilled person would directly and unambiguously recognise that "(ii) the feature is not, as such, indispensable for the function of the invention in the light of the technical problem the invention serves to solve"[27].

Notable case law includes:

EPO Case T284/94: "An amendment of a claim by the introduction of a technical feature taken in isolation from the description of a specific embodiment is not allowable under Article 123(2) EPC if it is not clear beyond any doubt for a skilled reader from the application documents as filed that the subject-matter of the claim thus amended provides a complete solution to a technical problem unambiguously recognisable from the application. Thus a generalisation of an embodiment can be allowed if the underlying recognizable function for that embodiment is still performed by the generalised features." (emphasis added)

EPO Case T1067/97: "If a claim was to be restricted to a preferred embodiment, it was normally not admissible under Art. 123(2) EPC to extract isolated features from a set of features which had originally been disclosed in combination for that embodiment. An amendment of this nature would only be justified in the absence of any clearly recognisable functional or structural relationship among said features." (emphasis added)

Therefore, based on the above, if a feature is added to a claim, then other features functionally related to the added feature should be added as well. In other words, an amendment can be allowed if it ensures that the underlying recognisable function is still performed by the features added to the claim. A synthesis of these Article 123(2) cases leads to the conclusion that whenever a function is recognisable to the skilled reader from the application as originally filed and in the light of common general knowledge, the feature or combination of features that is responsible for that function may be introduced into a claim without contravening Article 123(2) EPC.

Additional case law of the Boards of Appeal has recently criticized the test for intermediate generalization, in particular taking issue with the arbitrariness of the assessment of essentiality and with the ability of the essentiality test to be equally applicable to additions as well as removals.

EPO case T1852/13:

The Enlarged Board of Appeal discarded the approach based on the essentiality of the invention adopted in decision T 73/88 in relation to the validity of priority and established a criterion similar to the gold standard (see point 2.2.4 above). The concerns of the Enlarged Board of Appeal regarding the arbitrariness of the assessment of essentiality can also be applied to instances where amendments have been made. As a result, the Board agrees with decision T 910/03 that the ratio decidendi of opinion G 2/98 advocates no further application of the essentiality test. (commenting on G2/98 related to essentiality and priority, emphasis added)
....
It is also questionable whether the essentiality test actually maintains the legal certainty of third parties; the statements made in point 8.3 of opinion G 2/98 instead suggest that criteria that are based on essentiality reduce legal certainty. The gold standard is also superior to the essentiality test in that it represents a uniform benchmark for all amendments and is equally applicable to removals and additions. (commenting on decision T404/83, emphasis added)

In this connection EPO case T1852/13, while affirming the gold standard, also acknowledges the difficulties of its application and the need for objective criteria, as the lack thereof is the apparent basis of the Board's position on the "essentiality test".

EPO case T1852/13:

"The difficulty in applying the gold standard in specific cases has led to a number of attempts being made to introduce examination criteria that are specific and easy to apply. The problem with these "tests" is that they are based on individual cases which turn considerations relevant to the decision into generalized criteria. The validity of such generalizations is then not usually questioned. Outside the area of overlap in which the test leads to the same conclusions as application of the gold standard, however, there may be areas in which the test produces different results. Considerable caution should therefore always be taken when using such tests.

"The Enlarged Board of Appeal described this approach as "problematic" because there were no suitable and clear objective criteria for distinguishing between technical features which were connected to the function and the effect of the invention and technical features in which this was not the case, so there was therefore a risk of arbitrariness (see point 8.3 of the Reasons for the Decision)..(commenting on G2/98 and the essentiality test as applied to priority, emphasis added)

We note that the above passages of T1852/13 essentially confirm the premises of this paper and essentially affirm the need of uniform and objective criteria that are universally applicable to all fields and all situations.

It is apparent to the authors of this paper that an introduction of guidelines using structural and parametric variant-related features (or combination of features) and related functional properties as criteria would provide criteria that respond to the needs indicated by T1852/13 further elaborating the test of intermediate generalization, possibly replacing and/or further clarifying the indication concerning the "essentiality".

In general, new guidelines that provide more guidance by using structure/function and related relationships would guide users to draft applications in a way that would also minimise added matter issues later during prosecution - in view of the presence of corresponding criteria in guidelines/case law for evaluating support under Article 84 EPC and added matter under Article 123(2) EPC.

Articulation of the existing EPO analysis for support, clarity and added matter in terms of structure and function and related relationship would allow an internal harmonization of the related criteria

Contrary to what happens in the US, the EPO added matter requirement has a legal basis[28] different from the legal basis for support in the description[29]. The texts of Article 123(2) EPC (added matter) and Article 84 EPC (support) do not cross-reference one with the other. Under Article 123(2), "[t]he European patent application or European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed.", while under Article 84 EPC "the claims shall ...be clear and concise and be supported by the description."

The two requirements, however, both require an evaluation of the description and as such shall in practice be coordinated in evaluating what is described, conveyed or disclosed by the description. The coordinated application of Article 84 EPC and Article 123(2) EPC is discussed in the EPO Guidelines[30]. It concerns support and extent of generalization permissible under Article 84 and indicates that "the applicant should be allowed to cover all obvious modifications of, equivalents to and uses of that which he has described. .... After the date of filing, however, he should be allowed to do so only if this does not contravene Art. 123(2)."[31]

Therefore, in the EPO procedure, the mechanics of the legal reasoning concerning the description and what the description supports involve an evaluation of the extent of generalization allowed by Article 84 EPC (and logically also Article 83 EPC) together with an evaluation of its limits provided by the constraints of Article 123(2) EPC.

In this evaluation, Article 123(2) EPC and related rules and case law provide negative criteria defining the limits of support, while Article 84 EPC and related rules and case law provide positive criteria defining what instead is supported and the extent of generalization allowed. Accordingly, Articles 123(2) and 84 (as well as 83) EPC are in fact the "yin and yang" of the evaluation of added matter in Europe. In stark contrast with the US system, Article 123(2) EPC per se only provides limits, but not criteria, to positively identify modifications which are supported in the description.

Therefore, when analyzing amendments for added matter, the criteria of Article 123(2) EPC should be applied to define what is added matter, but at the same time it would be useful if criteria analogous to those of Article 84 EPC (and Article 83 EPC) could be applied during the same evaluation to determine when new features do not constitute added matter.

Articulation of the existing EPO analysis for support, clarity and added matter in terms of structure, function and their correlation would allow harmonization of the criteria with the US system

If the EPO Guidelines would adopt the US criteria of "structure, function, and their correlation" for support, clarity and added matter, then not only would the EPO criteria be harmonized with the US criteria, but they would also provide harmonization within the EPO Guidelines themselves, avoiding conflicts between different EPC rules. This would simplify the process for trans-national applicants by a reduction of conflicting rules.

Conclusions

Modification of the EPO Guidelines to emphasize use of structure, function, and their correlation in the analysis of written description would benefit understanding of the EPO criteria by US applicants and provide a convergence of the EPO practice with US practice.

More notably, we are not advocating for the adoption of any specific tests or specific wording of the rules, as these may vary in view of an ever evolving case law for each jurisdiction. Instead, we are advocating for a change in mindset, to take into account the need to develop a objective and universally applicable set of criteria/tools that can be used to articulate those tests in a way that makes them understandable to all applicants, including applicants from jurisdictions that do not share the same backgrounds and traditions.

Any efforts in this direction would help the development of a common language of patent practice, and would contribute to achieve an increased understanding of the requirements of the EP system by all users and, ultimately, promote harmonization across jurisdictional boundaries.

Abstract

Structure and function are key criteria in developing the legal reasoning in the US and Europe as well as many other jurisdictions. Development of guidelines articulating and explaining legal requirements in terms of structure and function would be understandable to all applicants, including applicants from jurisdictions that do not share the same backgrounds and traditions, as based on objective and universally applicable set of criteria/tools.

Any efforts in this direction would help the development of a common language of patent practice, and would contribute to achieve an increased understanding of the requirements of the EP system by all users and, ultimately, promote harmonization across jurisdictional boundaries.


  1. 35 USC and 37 CFR, and related caselaw
  2. See, for examples, Steve Hansen's "Patent 'Trolls': Effects of the U.S. Written Description Requirement and Continuation Practice" (https://hanseniplaw.com/patent-trolls-effects-of-the-u-s-writtendescription-requirement-and-continuation-practice/), Martin D. Hyden and Theresa M. Weisenberger's "Intermediate Generalization: Amending European Patents and Applications Under Article 123(2) EPC" (http://www.finnegan.com/files/upload/Newsletters/Full_Disclosure/2014/March/FullDisclosure_Mar14_4.html), and Jens Viktor Nørgaard and Rebecca M. McNeill's "Considerations for US Patent Attorneys When Drafting Patent Applications to Maximize Prosecution Opportunities in Europe" (http://www.mcneillbaur.com/docs/Considerations-for-USPatent-Attorneys-When-Drafting-Patent-Applications-to-MaximizeProsecution-Opportunities-in-Europe.pdf)
  3. See http://www.fiveipoffices.org/activities/harmonisation.html
  4. See TurboCare. v. General Electric Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001)
  5. In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983); Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) also MPEP 2163.02
  6. See TurboCare. v. General Electric Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001)
  7. 35 USC 132 and 35 USC 112(a), respectively
  8. See MPEP 2163.I, and MPEP 2163.02 "'Identifying characteristics are also used to determine: Whether the specification conveys with reasonable clarity ... applicant was in possession of the invention as now claimed' (Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563 - 64 Fed. Cir. 1991)"
  9. MPEP 2163.II
  10. MPEP 2163.II (emphasis added)
  11. Amgen Inc. v. Sanofi, Aventisub LLC, 2017 U.S. App. LEXIS 19416 (Fed. Cir. Oct. 5, 2017)
  12. Id above p. 17
  13. TurboCare v. General Electric Co., 264 F.3d 111, 1118 (Fed. Cir. 2001) "The written description requirement and its corollary, the new matter prohibition of 35 U.S.C. 132, both serve to ensure that the patent applicant was in full possession of the claimed subject matter on the application filing date."
  14. Guidelines for Examination in the European Patent Office" (Nov. 2016), http://documents.epo.org/projects/babylon/eponet.nsf/0/0791474853510FFFC125805A004C9571/$File/guidelines_for_examination_en.pdf
  15. "Guidelines for Examination in the European Patent Office" (Nov. 2016), Part F, Chapter IV, Section 6.2; emphasis added.
  16. See "Guidelines for Examination in the European Patent Office" (Nov. 2016), Part F, Chapter IV, Section 6.2
  17. MPEP 2163.II
  18. https://www.epo.org/law-practice/case-law-appeals/case-law.html
  19. "Case Law", page 256.
  20. See case T720/92
  21. "Guidelines for Examination in the European Patent Office" (Nov. 2016), Part F, Chapter IV, Section 6.2
  22. "Guidelines for Examination in the European Patent Office" (Nov. 2016), Part H, Chapter IV, Section 2.2
  23. Id. at Section 2.3
  24. Id. at Part H-IV, Section 2.2 and Part G-VI, Section 2
  25. G 0001/93, Reasons for the Decision #16
  26. "Guidelines for Examination in the European Patent Office" (Nov. 2016), Part H, Chapter V, Section 3.2.1
  27. Id. at Section 3.1, re: replacement/removal of a feature
  28. Article 123(2) EPC
  29. Article 84 EPC
  30. "Guidelines for Examination in the European Patent Office" (Nov. 2016), Part F, Chapter IV, Section 6.2
  31. Id.

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