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
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/04/2026 has been entered.
Claims 1-22 have been examined.
Grounds of Objection and Rejection Withdrawn
Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 09/04/2025.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
5. The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
6. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 13, 16-18 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 13, 16-18 and 21 recite the limitation "therapeutic biologic" in lines 1-2. There is insufficient antecedent basis for this limitation in the claims.
8. 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.
9. 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.
10. Claims 1-10 and 12-22 remain 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.
This is a “written description” rejection.
The considerations that are made in determining whether a claimed invention is supported by an adequate written description are outlined by the published Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, ``Written Description'' Requirement (Federal Register; Vol. 66, No. 4, January 5, 2001; The 2015 Written Description Workshop materials; hereinafter “Guidelines”).
These guidelines state that rejection of a claim for lack of written description, where the claim recites the language of an original claim should be rare. Nevertheless, these guidelines further state, “the issue of a lack of written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant has possession of the claimed invention” (Id. at 1105). The “Guidelines” continue:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
With further regard to the proposition that, as original claims, the claims themselves provide in haec verba support sufficient to satisfy the written description requirement, the Federal Circuit has explained that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement:
Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). See also: University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 1892 (CA FC 2004).
Thus, an original claim may provide written description for itself, but it must still be an adequate written description, which establishes that the inventor was in possession of the invention.
The claims are herein drawn to a composition comprising a therapeutic agent and co-formulated with a hyaluronan degrading agent for administration to a subject by injection.
In this instance, the claims are directed to a genus of therapeutic agents co-formulated with a hyaluronan degrading agent for administration to a subject by injection.
A genus of therapeutic agent may include, for example, a polypeptide, an antibody, a nucleic acid, or small molecule.
Although the specification teaches antibody or protein particles (see Examples 1-15), it is not representative of the claimed a genus of therapeutic agents; this is because the claimed therapeutic agent, for example, a polypeptide, an antibody, a nucleic acid, or small molecule have markedly different structures. The artisan would not expect that any given therapeutic agent would be used to co-formulate with a hyaluronan degrading agent for administration to a subject by injection.
Because prior art, Teran et al. (US 20190142957, published on 05/16/2019, IDS) teach “hyaluronidase has not been successful in converting every drug tested to a subcutaneous administration. It is not predictable whether or not the addition of hyaluronidase will meet the requirements for subcutaneous administration of any given drug product” (see [0324] of Teran et al.). Thus, in view of Teran et al., one ordinary skill in the art would not reasonably predict or expect that adding a hyaluronan degrading agent to the composition as claimed would result in successful subcutaneous administration.
There is no correlation between any one particularly identifying structural feature that is shared by at least a substantial number of the members of the claimed a genus of therapeutic agent; because each therapeutic agent is structurally and functionally different. Although the artisan could potentially screen therapeutic agents, it cannot be predicted whether or not one will be successful. The written description provision set forth under 35 USC 112(a) is severable from its enablement provision, so that written description requirement cannot be met by describing how one might make the invention – rather the invention must be described in such clear and particular terms so as to reasonably convey to the skilled artisan that applicant had possession of the claimed invention as of the filing date of the application (i.e., the earlier effective US filing date sought).
The skilled artisan could not immediately envision, recognize or distinguish at least a substantial number of the members of the claimed genus of therapeutic agents.
The specification therefore would not reasonably convey to the skilled artisan Applicant's possession of the claimed invention as of the filing date of the application.
Notably, the Federal Circuit has decided that a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. See Noelle v. Lederman, 69 USPQ2d 1508 1514 (CA FC 2004) (citing Enzo Biochem II, 323 F.3d at 965; Regents, 119 F.3d at 1568).
Furthermore, Applicant is reminded that “generalized language may not suffice if it does not convey the detailed identity of an invention.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1892 (CAFC 2004).
In this instance, there is no language that adequately describes with any of the requisite clarity or particularity the claimed a genus of therapeutic agents would be used to co-formulate with a hyaluronan degrading agent for administration to a subject by injection. A description of what a material does, rather than of what it is, does not suffice to describe the claimed invention.
While the written description requirement can by satisfied without an actual reduction to practice, the disclosure of a catalog of potentially effective substances that might be found to be useful in practicing the claimed invention does not fulfill the written description requirement.
Recognizing that the claims are drawn to a genus of therapeutic agents would be used to co-formulate with a hyaluronan degrading agent for administration to a subject by injection, it is aptly noted that the Federal Circuit has decided that a generic statement that defines a genus of substances by only their functional activity, does not provide an adequate written description of the genus. See The Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The Court indicated that while applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a precise definition of a representative number of members of the genus, such as by reciting the structure, formula, chemical name, or physical properties of those members, rather than by merely reciting a wish for, or even a plan for obtaining a genus of molecules having a particular functional property. The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of genus must be capable of doing, not of the substance and structure of the members.
Finally, Guidelines states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was ‘ready for patenting’ such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” (Id. at 1104). “Guidelines” further states, “[f]or 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” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. Moreover, because the claims encompass a genus of therapeutic agents would be used to co-formulate with a hyaluronan degrading agent for administration to a subject by injection, but which otherwise vary materially, structurally and/or functionally, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. In this instance, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; Applicant has not shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; and Applicant has not described distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention at the time the application was filed.
Double Patenting
11. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 1-22 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of copending Application No. 17/883427 (allowed on 02/09/2026). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-22 are herein drawn to a composition comprising particles, wherein a plurality of the particles comprises greater than 65% of a therapeutic agent by weight; wherein the composition is co-formulated with a hyaluronan degrading agent in a volume of less than 2.5 mL; and wherein the particles dissolve upon administration to a subject by injection, wherein the therapeutic agent is an antibody, wherein the particles are suspended in a carrier, wherein the carrier comprises ethyl oleate.
Claims 1-18 of copending Application No. 17/883427 are drawn to a pharmaceutically effective composition comprising particles suspended in a carrier comprising fatty acid esters, wherein a plurality of the particles comprises at least one antibody or a fragment thereof, wherein the total weight percent of the at least one antibody or the fragment thereof in the plurality of particles is greater than 65%, and wherein the composition further comprises a hyaluronan degrading agent.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
13. No claim is allowed.
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/YAN XIAO/Primary Examiner, Art Unit 1642