DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/18/26 has been entered.
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 12/12/2024 is acknowledged.
Claims 12 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/24.
Claims 1, 2, 5-8, 11 and 14-20 are examined on the merits.
Response to Arguments
Applicant's arguments filed 5/18/26 have been fully considered but they are not persuasive. See response below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
(Prior Rejection Maintained and extended to additional limitations) Claims 1, 2, 5-8, 11 and 14-20 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
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... reduction to drawings...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 BU Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 1, 2, 5-8, 11 and 14-20 are rejection for lacking adequate written support for a:
Claim 1: A composition comprising one or more pharmamers, each pharmamer comprising two or more immunologically active molecules attached to one or more multimerization domains, wherein the two or more immunologically active molecules comprise one or more antibody molecules against CD3 and/or one or more antibody molecules against CD28, and wherein the one or more multimerization domains comprise a dextran molecule; and
Claim 8: A pharmamer comprising (1) two or more immunologically active molecules, wherein the two or more immunologically active molecules comprise one or more antibody molecules against CD3 and/or one or more antibody molecules against CD28, and (ii) one or more multimerization domains comprising a dextran molecule, wherein the two or more immunologically active molecules are attached to the one or more multimerization domains.
Specifically, the antibodies for CD3 and/or CD28 lack adequate written support.
The dependent claims do not elaborate on the antibody molecules required by claims 1 and 8. More specifically, the dependent claims do not provide specific structural limitations for these antibodies.
In support of the claimed genus of an “two or more immunologically active molecules” and “antibody molecules against CD3 and/or … CD28…”. The specification discloses 3 specific antibodies (OKT3, UCHT1 and 17A2) which bind CD3 and 3 specific antibodies (CD28.2, 9.3 and theralizumab) which bind CD28. No other examples of antibodies are disclosed, including mutants or variants thereof.
In addition, within the claimed limitation of immunologically active molecules and antibodies that function as such, the specification states: “In many applications, it will be advantageous that the pharmamer comprises one or more Immunologically active molecules. Immunologically active molecules are compounds that can modulate the immuno-activity of the pharmamer itself or the immune system as such, by affecting binding characteristics or effects of the pharmamer. A pharmamer can comprise several immunologically active molecules which can be the same or different. Immunologically active molecules are a subgroup of biologically active molecules for example proteins, co-stimulatory molecules, cell modulating molecules, receptors, accessory molecules, adhesion molecules, natural ligands, and toxic molecules, antibodies, MHC molecules, TCR’s and recombinant binding molecules to any of the foregoing, and combinations thereof.” [see page 33 of instant specification at lines 16-27] Of note, this identified section of the specification elaborates on the broad function of the claimed antibodies as they also function as immunologically active molecules, since such antibodies are able to “…modulate the immuno-activity of the pharmamer itself or the immune system as such, by affecting binding characteristics or effects of the pharmamer.” This would imply that the CD3 and CD28 antibodies are able to be immunologically active against the pharmamer, which comprises these antibodies and/or the immune system. As stated above, applicants have disclosed 3 specific antibodies (OKT3, UCHT1 and 17A2) which bind CD3 and 3 specific antibodies (CD28.2, 9.3 and theralizumab) which bind CD28, but these antibodies are not immunologically active against the pharmamer, rather, they bind to CD3 or CD28.
Thus, the application fails to provide a representative number of species of antibodies that can bind to CD3 or CD28 and/or also performing the functions of being immunologically active against the pharmamer.
Moreover, the decision arrived at in Amgen v. Sanofi, 598 US 594 (2023), supports expanded analysis of whether a claim drawn to an antibody being specific for an epitope, even a specific epitope, permits an applicant to pursue all possible antibodies that are capable of being produced against such an epitope. Presently, the claimed pharmamer possesses an antibody molecule(s) against CD3 and/or CD28 is only defined by the ability to bind to these cellular proteins. In view of the fact patterns detailed in Amgen v. Sanofi, applicants are not in possession of a pharmamer with antibody molecules against CD3 and/or CD28.
In view of this uncertainty and the lack of a representative number of examples of the claimed genus, the claims are rejected for lack of adequate written description support.
Response to arguments:
Applicant’s arguments have been fully considered, however, they are not persuasive.
Applicant’s present Exhibits A and B and arguments, which focus on information provided by what appears to be an artificial intelligence (Google Gemini) search of antibodies for CD3 and CD28. It is not clear when this search was conducted, but the information presented in the search can change each day or as the Google search algorithm is edited. Therefore, information provided by the AI search tool relative to the claimed invention would not be interpreted at reliable. Furthermore, the information presented does not place the applicant in possession of the claimed composition since specific details from each identified CD3 or CD28 antibody are not provided and it would appear that many of the identified CD3 or CD28 specific links are related to internet websites or linked documents having a publication date after applicants earliest priority date (October 2, 2008). In addition, if an antibody specific for CD3 or CD28 existed before applicant’s priority date, what was known about the antibody and how it may function in relation to the claimed invention is not known nor has it been studied. Therefore, this information does not aid in the explanation of what was known in the prior art and in applicant’s disclosure in order to overcome this rejection.
As stated in the previous Office action, while applicants have pointed to 3 specific antibodies (OKT3, UCHT1 and 17A2) which bind CD3 and 3 specific antibodies (CD28.2, 9.3 and theralizumab) which bind CD28, these species do not place applicants in possession of the genus of a composition comprising one or more pharmamers that comprises an antibody molecule against CD3 or CD28. Since the claimed antibody is against CD3 or CD28, this only describes what the antibody can bind without providing a structure of the antibody. Contrary to applicant’s statement that “Since any antibodies having such binding affinity are within the scope of claim 1, their specific structure is not relevant to the invention, and are not part of the invention.”, the claimed invention requires an antibody against CD3 or CD28, and therefore, are interpreted to be part of the invention. If applicants are suggesting that an antibody against CD3 or CD28 isn’t part of the invention, then it would appear that the claimed invention is only drawn to a composition comprising dextran.
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.
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.
(New Rejections) Claims 1, 2, 5-8, 11 and 14-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention
Claims 1 and 8 recite the limitation "…one or more antibody molecules against CD3 and one or more antibody molecules against CD28…”.
This limitation is unclear because “antibody” is defined as: “As used herein, the term "antibody" means an isolated or recombinant binding agent that comprises the necessary variable region sequences to specifically bind an antigenic epitope. Therefore, an antibody is any form of antibody or fragment thereof that exhibits the desired biological activity, e.g., binding the specific target antigen.” [see page 3, lines 21-25 of specification] Therefore, the word “antibody” includes monoclonal (mAb) and polyclonal antibodies (pAb) or fragments thereof. Therefore, the claim encompasses polyclonal antibodies with the six CDRs. However, polyclonal antibodies have many and different antibody species. The CDRs or variable regions could be found on one molecule in the pAb or two. The claim can be clarified by the following claim amendments: adding “monoclonal” to the limitation.
Appropriate correction is required. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
Claims 2, 5-7, 11 and 14-20 are also rejected because they depend from claim 1 or 8, but do not remedy this deficiency.
Claims 1 and 8 recite: “wherein one or more multimerization domains comprise a dextran molecule”, however, it is unclear if the dextran molecule is the only molecule providing the one or more multimerization domains since the claim recites “comprise a dextran molecule”. Page 7, at lines 29-35 also state that such domains include polymers, proteins, micelles, cells, beads, etc.
Claims 2, 5-7, 11 and 14-20 are also rejected because they depend from claim 1 or 8, but do not remedy this deficiency.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached on (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
Prosecution Insights