Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/17/2026 has been entered.
Status of Claims
Claims 28-44 are pending and under examination in the instant application.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 2/20/2026 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 7/17/2026.
Status of Rejections
35 USC § 112 (a)
The rejection of claims 28-44 is maintained.
Applicant’s arguments, see Remarks, filed 7/17/2026, with respect to the rejection set forth in the Non-Final Office Action mailed 2/20/2026, have been fully considered but are not found persuasive.
To reiterate the rejection, the skilled artisan would not have adequate reason to believe that Applicant had possession of the claimed genus shown in claim 28 based on the information provided in the specification. The only working examples described in the specification that consist of a proper Markush grouping consist of the following:
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The claimed articles consist of various linkers that are not viewed as equivalents in the art. No where does the specification allude to other articles comprising the latter within a proper Markush claim. Thus, how would one skilled in the art expect that Applicant was indeed of possession of the claimed genus if only a few working embodiments were presented in the disclosure? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p). Note also the following:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation.
The courts have applied this criteria in a more recent decision stating the following referencing genus claims drawn to chemical compounds:
“For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” see Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010).
Therefore, based on the lack of working examples, nature of the described genus, and new matter (see rejections herein); Applicants are not in possession of the claimed genus.
Applicants argue that the limited claim scope meets the written description requirement. Again the examiner states that this limited number of species is insufficient to show possession of the entire genus of articles claimed in particular with respect to formula B-I. The scope of the claims may encompass millions of different species comprising various linkers that are not viewed as equivalents in the art. Additionally the linkers provided in the examples appear to consist of only one common linkage moiety comprising a carbonate moiety:
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There are no other working examples consisting of different linkers besides those mentioned above. Thus, how would one skilled in the art expect that Applicant was indeed of possession of the claimed genus if only a few working embodiments were presented in the disclosure? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p). Note also the following:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Thus based on the limited number of working examples; Applicants could not possibly be in possession of the claimed genus.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 28-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
For example, claim 28 with respect to the formula B-I has been amended extensively to recite subject matter (e.g. variable L is RA) that raise the issue of new matter. Applicant has not provided any guidance as to where to find support for these amendments in the instant disclosure.
See MPEP § 2163.06, “with respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims”. A statement such as “No new matter has been added by these amendments that are supported by the specification” is insufficient.
The examiner thus will look to the specification for support. At page 14, the following structure now recited and definitions associated with it therein are shown below:
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Note that the language is not commensurate in scope with what is recited in the instant claims in particular wherein variable L is defined as RA.
Thus, the rejection is appropriately applied. An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/ Primary Examiner, Art Unit 1624
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