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
Election/Restrictions
Claims 34-47, 54, and new claims 55-83 are now under consideration in the instant Office Action.
Withdrawn Objections
Objections to claim 1 due to minor informalities is hereby withdrawn due to the cancellation of claim 1.
Withdrawn Rejections
Rejections of claims 52-53 under 35 U.S.C. 35 112(b) and 101 as “use” claims that set forth processes of using a pharmaceutical composition to treat cancer in a subject are hereby withdrawn in view of amendments to the claims.
New Rejections
Claim Rejections - 35 USC § 112
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.
Instant claims 44-45, 59, 73, and 77 recite the term “optionally”. The phrase “optionally” is interpreted as "for example" which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For the purposes of examination, the instant claims will be interpreted without the optional limitations as they are not required or claimed as necessary to the invention.
Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
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.
Claims 43 and 64 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.
Instant claims 43 and 64 recite the term “biosimilar or equivalent thereof”. It is unclear what is encompassed by the term “biosimilar”, or what is encompassed within the term “equivalent”. The specification as filed defines the term “biosimilar” vaguely as “a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components with no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity and potency”, see paragraph 0038. The specification as filed does not provide sufficient instruction on what this term intends to convey or encompass.
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
Applicant argues “the term “biosimilar” is a well-known term in the art” and “those of skill in the art would find claim 43 clear when the claim is read in light of the specification and in view of the general knowledge in the art”. This is not found persuasive.
While the terminology “biosimilar” is known in the art, the recitation of the terminology in the claim leaves aspects of the structure undisclosed and renders the claim unclear. The instant claim limitations leave the metes and bounds of the claims ambiguous and unclear. It is unclear what is encompassed by the terminology and if Applicant has adequate support for it in the instant specification, since the terminology extends beyond what is recognized in the prior art and specification.
Thus, the rejection is maintained.
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.
Claims 43 and 64 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.
See MPEP §2163(I)(A) which states: "The claimed invention as a whole may not be adequately described 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 biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
Claims 43 and 64 call for a “biosimilar” equivalent of amivantamab with a functional requirement of treating cancer. There is no specific structural requirement for the biosimilar equivalent beyond the required function. The required function of the agent can be achieved in any form, no specific structure is required, as long as they are “a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components with no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity and potency, based upon data derived from (a) analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; (b) animal studies (including the assessment of toxicity); and/or (c) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biosimilar”, see paragraph 0038 of the instant specification. The scope of the claim is so broad and reads on so many possible genera that it is clear that the specification fails to describe all of the possible means of achieving the response linked to its function. The claims do not require any agent or that they possess any particular conserved structure or other disclosed distinguishing features aside from an undefined “similarity”. Therefore, the genera are merely defined by function and the instant specification fails to describe the full genera of the possible methods that are encompassed by these claims.
There is no structural requirement for the claimed biosimilar equivalent to amivantamab beyond function. Instant claims 43 and 64 do not even have a functional requirement and only a generic polypeptide structure defined by its similarity. The claimed activity of the agents can be achieved in any form as long as the agents provide the specifically claimed function.
There are a few specific examples of a bispecific EGFR-cMet antibody, also referred to as “amivantamab”, in the instant specification, but there is no support provided that the applicants have envisioned all of the possible variants encompasses by these functional requirements of the instant claims. The scope of the term “biosimilar” is so broad and reads on so many possible genera that the instant specification fails to describe any of the possible equivalents that are encompassed by this term. The “biosimilar” encompasses any agent that has the required function but the instant specification fails to teach all the possible agents encompassed by the possible agents in the instant claim. The claims do not require that the “biosimilar” equivalent of amivantamab possesses any particular conserved structure or other disclosed distinguishing feature. The term “biosimilar” encompasses many things including antibodies, proteins, peptides, hormones, small drugs, or other drugs as long as they achieve the required function. Thus the claims are drawn to multiple genera of molecules that are defined only by they function as a chemotherapeutic. Therefore, the genus is merely defined by function and the instant specification fails to describe the full genus of molecules that are encompassed by this claim.
To provide adequate written description and evidence of possession of claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of prospective activity or function. There is not even identification of any particular portion of the structure that must be conserved for said activity except its function. The specification does not provide a complete structure of all possible forms of the claims agents and variants and fails to provide a representative number of species for any genera. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genera of KA2 variants cargo polypeptides or the agents.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed structure of the encompassed agents, fragments and variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
Applicant argues “if a skilled artisan would have understood the inventor to be in possession of the claimed invention at the time of filing, even if every nuance of the claims is not explicitly described in the specification, then the adequate description requirement is met”. This is not found persuasive.
As discussed in the rejection supra, the scope of the term “biosimilar” is broad and reads on many possible genera that the instant specification fails to describe any or all of the possible equivalents that are encompassed by this term. The “biosimilar” encompasses any biologic medication already approved by the FDA that has the required function, but the instant specification fails to teach all the possible biologics encompassed by the possible structures in the instant claim. Applicant discusses certain criteria for how a biosimilar equivalent is determined on page 3 of the Remarks, and this is sufficient in considering potential future embodiments of the antibodies of the instant claims. However, when the terminology is introduced into the claims, there remains a lack of written description as the number of potential biologics that can fit within the scope of the claims is immense and remains undefined. The differences between the antibody as defined by the sequences and the biosimilar equivalents has not been ascertained to a requisite degree to account for all the permutations and/or differences in structures of what has not been defined. While Applicant argues that the biosimilar equivalents “have no clinically meaningful differences from the reference product”, this is at best a functional description of what the antibody can do and lacks the necessary structural information to obviate the written description rejection. All of the potential biosimilar equivalents that fit this functional description have not been described in the specification as filed.
Thus, the rejection is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 34-47, 54, and new claims 55-83 are rejected under 35 U.S.C. 103 as being unpatentable over Yun et al. (in PTO-892 filed 12/23/2025), in view of Das et al. (US 2011/027262 A1, in IDS filed 09/23/2024) and Keller et al. (US 9,833,498 B2, in IDS filed 09/23/2024).
Yun et al. teaches the use of “amivantamab (JNJ-61186372), a bispecific antibody targeting EGFR–MET, has shown preclinical activity in TKI-sensitive EGFR-mutated non-small cell lung cancer (NSCLC) models and in an ongoing first-in-human study in patients with advanced NSCLC”, see Abstract. The amivantamab “inhibited proliferation by effectively downmodulating EGFR–MET levels and inducing immune-directed antitumor activity with increased IFNγ secretion in various models”, see Abstract. The instant specification provided by Applicant recites embodiments 6-10 on pages 42-43, which include antibody sequences that comprise the bispecific EGFR-cMet antibody “amivantamab or a biosimilar thereof”. These sequences which constitute amivantamab or a biosimilar equivalent thereof comprise an HC 1 variable region comprising the amino acid sequence of SEQ ID NO:13, a LC1 variable region comprising the amino acid sequence of SEQ ID NO:14, a HC2 variable region comprising the amino acid sequence of SEQ ID NO:15, and a LC2 variable region comprising the amino acid sequence of SEQ ID NO:16; or the HC1 comprises the amino acid sequence of SEQ ID NO:17 and the LC1 comprises the amino acid sequence of SEQ ID NO:18; the HC2 comprises the amino acid sequence of SEQ ID NO: 19 and the LC2 comprises the amino acid sequence of SEQ ID NO:20. Additionally, the sequences for the twelve CDRs SEQ ID NOs: 1-12 are encompassed within the larger heavy and light chain sequences. As such, the antibody of the instant claims and the antibody of Yun et al. are structurally identical. This meets the limitations of instant claims 34, 36-45, 54, 61-64, and 83 wherein the sequences for the antibodies are taught and the composition containing the antibody amivantamab is used in a method to treat cancer, specifically non-small cell lung cancer. Instant claim 54 is drawn to a method of reducing infusion-related reactions by administering the antibody of the instant claims and is therefore taught by the reference as the structure and methods confer the functionality of the composition. It would be reasonable to expect that the antibody in the prior art and instant claims would function identically as it was taught in the prior art.
Yun et al. is silent on formulations for bispecific antibodies. Das et al. remedies this deficiency.
Das et al. teaches a formulation for an antibody with a concentration of “0.1 mg/mL to about 200 mg/mL”, see paragraph 0206. Das et al. also teaches that “in some embodiments, higher antibody concentrations can be used where the composition is intended for subcutaneous delivery”, see paragraph 0171. This meets the limitations for instant claims 34-35, 38, 44-45, 54-59, 65, wherein the antibody concentration is about 144 mg/mL to about 176 mg/mL or 1,050 mg to about 3,500 mg of the bispecific antibody when adjusted for total volume and is delivered subcutaneously.
Das et al. teaches “suitable buffers include, but are not limited to, acetate (e.g., sodium acetate)… in various embodiments, the concentration of the buffer is about 1 mM… to about 30 mM…. to about 50 mM”, see paragraphs 0183-0185. This meets the limitations of instant claims 38, 44-45, 59, 66-67, and 83 wherein the composition contains an acetate buffer that is in the form of a salt. Das et al. also teaches “the tonicity agent is sucrose and is present in the composition at a concentration of about 90 mg/ml”, see paragraph 0193. This meets the limitations of instant claims 38, 44-45, 59, 68, and 83 as 90 mg/mL is equivalent to about 9% w/v, which falls in the claimed range of 6.8% (w/v) to about 10.2% (w/v) of sucrose. Das et al. teaches “the composition contains 0.5 mg/mL polysorbate 80”, see paragraph 0199. This meets the limitations of instant claims 38, 44-45, 59, 69, and 83 as 0.5 mg/mL is equivalent to the claimed “0.036% w/v to about 0.084% w/v of polysorbate 80”.
Das et al. teaches “suitable antioxidants include, but are not limited to, methionine… for example, the composition may contain methionine in a concentration that ranges from 1 mM to about 100 mM, and in particular, is about 27 mM”, see paragraph 0201. This meets the limitations of instant claims 38, 44-45, 59, 70, and 83 as the reference teaches the amount from 1 mM to about 100 mM and encompasses the range of 5.4 mM to 8 mM, which is equivalent to 0.8 to 1.2 mg/mL as claimed. Das et al. also teaches “the chelating agent is selected from the group consisting of EDTA… about 0.05 millimolar”, see paragraph 0180. This meets the limitations of instant claims 38, 44-45, 59, 71, and 83 as 0.05 millimolar is equivalent to about 16 microgram/mL of EDTA. Das et al. teaches “the composition are typically buffered to maintain a pH in the range of … about 5.2 to about 6.3”, see paragraph 0186. This meets the limitations of instant 38, 44-45, 59, 72, and 83 wherein the recited pH is 5.2 to about 6.2.
Das et al. teaches “the skilled artisan will appreciate that the weight quantities and/or weight-to-volume ratios recited in the examples can be converted to moles and/or molarities using the art-recognized molecular weights of the recited ingredients. Weight quantities exemplified herein (e.g., grams) are for the volumes (e.g., of buffer solutions, antibody composition, etc.) recited. The skilled artisan will appreciate that the weight quantities can be proportionally adjusted when different composition volumes are desired”, see paragraph 0376. As such, the teachings of Das et al. meet the limitations of the instant claims 78-82 wherein the volume of the composition can vary in range depending on desired end result of the total volume of the composition. Given the specific quantities for the components of the composition, the skilled artisan is able to adjust quantities to obtain any desired volume. Additionally, the total amount of antibody concentration recited in the instant claims 55-59 are also taught by Das et al. as one of ordinary skill in the art could appropriately scale the formulation to achieve, for example, 2,400 mg of the bispecific antibody by adjusting the total volume of the composition to 15 mL when working with a concentration of 160 mg/mL of antibody, etc.
However, Yun et al. and Das et al. do not teach the use of hyaluronidase to aid in subcutaneous delivery. Keller et al. remedies this deficiency.
Keller et al. teaches a human hyaluronidase known as “rHuPH20” in SEQ ID NO: 229, which is a 100% match for instant SEQ ID NO: 25. This meets the limitations of instant claims 34, 38, 44-45, 54-55, 59-60, 73-76, and 83 wherein the hyaluronidase is human hyaluronidase and the reference teaches the instant sequence, and instant claims 74-76 wherein the human recombinant hyaluronidase enzyme is rHuPH20. Keller et al. also teaches “sub-epidermal administration includes, but is not limited to subcutaneous administration, intramuscular administration, intralesional administration and intradermal administration”, see pg. 23, col. 3. This meets the limitations of instant claims 35 and 54 wherein the administration is subcutaneous administration. Keller et al. also teaches dosages for matrix-degrading enzymes such as hyaluronidase as ranging from 1 mg to 5 mg in a 10-50 mL final volume solution, see pg. 63, column 83. This meets the limitations of instant claims 34-35, 38, 44-45, 55-60, 73-76 wherein the claimed dosages range from 1,000 U/mL to 3,000 U/mL of hyaluronidase which converts to 0.02 mg/mL, see instant specification pg. 22. The final dosage is 1.4 mg of hyaluronidase when using the standard adult body weight of 70 kg for determining drug administration.
Although the prior art references do not explicitly recite the term "kit” or an “article of manufacture” this limitation, i.e. "a commercial package" is the intended use of the composition recited by instant claims 44-47. The prior art compositions would be capable of performing this claimed use (see MPEP § 2111.02 (II)). Moreover, although the patent does explicitly recite the claimed “instructions for use,” the inclusion of nonfunctional printed material fails to distinguish a product over the prior art (see MPEP § 2112.01 (III)).
Instant claim 77 recites characteristics of the antibody in solution. Since the antibody and formulation recited in the instant claims has been taught by the prior art, the antibodies when stored and/or administered will produce the same results as the instantly claimed method since one is practicing the same active steps. MPEP 2145(II) states: “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)” (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).
It would be obvious at the time of the instant invention to use the sequences for the antibody taught by Yun et al., which are known to target tumor cells in NSCLC and be effective when used as a treatment against cancer, with the formulation taught by Das et al. which teaches a formulation that improves the stability of antibodies stored in solution, see paragraph 0084, with the hyaluronidase taught by Keller et al., which aids in subcutaneous delivery of high concentration antibodies. One would be motivated to combine the antibodies with the formulation with the expectation of treating cancer by targeting binding to multiple epitopes which are well known in the art to exist on tumor cells for chemotherapeutic effects. Keller et al. teaches the importance of the addition of hyaluronidase to an antibody formulation that is to be delivered subcutaneously, stating that “a selected matrix-degrading enzyme is included in an amount sufficient that, when activated, exert a therapeutically useful effect in the absence of undesirable side effects on the patient treated”, see pg. 62, column 82. In summary, Yun et al. teach the same bispecific EFGR/c-Met antibody as claim being used for the treatment of non-small cell lung cancer, Das et al. teaches the components of a formulation that is effective in preserving or stabilizing a therapeutic antibody such as a bispecific antibody, and Keller et al. teaches how to safely and effectively administer the antibody subcutaneously when using it as a cancer therapeutic.
Therefore, claims 34-47, 54, and new claims 55-83 are rejected as obvious over Yun et al., Das et al., and Keller et al.
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
Applicant argues that the amendments to the claims which now recite “methods of administering, or kits or articles of manufacture containing, a stable aqueous pharmaceutical composition comprising a bispecific epidermal growth factor receptor (EGFR)/hepatocyte growth factor receptor (c-Met) antibody and a hyaluronidase” are not taught by the combination of Yun, Das, and Keller. This is not found persuasive.
As discussed in the obviousness rejection above, the combination of Yun, Das, and Keller meet all the limitations of the claimed invention. Each of the references teach the limitations of the instant invention and discuss the motivations behind their taught uses and methods, as well as methods to tailor their teachings to a particular antibody or method of administration. One of ordinary skill in the art can acknowledge their intended uses and functions and recognize that the instant claims are drawn to the same end goal, thus motivating the skilled artisan to combine the teachings to arrive at the instant invention. In regards to the methods of administering and kits or articles of manufacture, these findings are commensurate in scope with what is taught in the prior art. Instant claim 54 is drawn to a method of reducing infusion-related reactions by administering the antibody of the instant claims and is therefore taught by the reference(s) as the structure and methods confer the functionality of the composition. It would be reasonable to expect that the antibody of the prior art and instant claims would function identically as it was taught in the prior art.
Although the prior art references do not explicitly recite the term "kit” or an “article of manufacture” this limitation, i.e. "a commercial package" is the intended use of the composition. The prior art compositions would be capable of performing this claimed use (see MPEP § 2111.02 (II)). Moreover, although the patent does explicitly recite the claimed “instructions for use,” the inclusion of nonfunctional printed material fails to distinguish a product over the prior art (see MPEP § 2112.01 (III)).
Therefore, the rejection is maintained.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 34-47, 54, and new claims 55-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 19/072,332, hereinafter ‘332. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite the same antibody, same formulation, and same methods of use.
‘332’s claims recite a stable aqueous pharmaceutical composition comprising a bispecific specific for epidermal growth factor receptor and cMET, and a hyaluronidase suitable for use against cancer. The following is a list of the instant claims that recite the same limitations as the corresponding claims of ‘332:
Instant claim 1 [Wingdings font/0xE0] ‘332’s claim 1 (identical sequences, same hyaluronidase)
Instant claim 10 [Wingdings font/0xE0] ‘332’s claim 2 (identical sequences, same limitations for formulation)
Instant claims 11, 12 [Wingdings font/0xE0] ‘332’s claim 3 (identical sequences)
Instant claims 13, 14 [Wingdings font/0xE0] ‘332’s claim 4 (identical sequences)
Instant claim 15 [Wingdings font/0xE0] ‘332’s claim 5 (same antibody)
Instant claim 16 [Wingdings font/0xE0] ‘332’s claim 6 (same concentration of antibody)
Instant claim 17 [Wingdings font/0xE0] ‘332’s claim 7 (same concentration of acetate salt)
Instant claim 18 [Wingdings font/0xE0] ‘332’s claim 8 (same species of acetate)
Instant claim 19 [Wingdings font/0xE0] ‘332’s claim 9 (same concentration of sucrose)
Instant claim 20 [Wingdings font/0xE0] ‘332’s claim 10 (same concentration of PS80)
Instant claim 21 [Wingdings font/0xE0] ‘332’s claim 11 (same concentration of methionine)
Instant claim 22 [Wingdings font/0xE0] ‘332’s claim 12 (same concentration of EDTA)
Instant claim 23 [Wingdings font/0xE0] ‘332’s claim 13 (same pH value for formulation)
Instant claim 24 [Wingdings font/0xE0] ‘332’s claim 14 (same sequence for hyaluronidase)
Instant claim 25 [Wingdings font/0xE0] ‘332’s claim 15 (same concentration of rHuPH20)
Instant claim 26 [Wingdings font/0xE0] ‘332’s claim 16 (same concentration of rHuPH20)
Instant claim 32 [Wingdings font/0xE0] ‘332’s claim 17 (same limitations for formulation)
Instant claim 33 [Wingdings font/0xE0] ‘332’s claim 18 (same limitations for formulation)
Instant claim 34 [Wingdings font/0xE0] ‘332’s claim 19 (same method of treating cancer using the same pharmaceutical composition)
Instant claim 35 [Wingdings font/0xE0] ‘332’s claim 20 (same method of administration)
Instant claim 36 [Wingdings font/0xE0] ‘332’s claims 21, 23, 24 (same species of cancer)
Instant claim 37 [Wingdings font/0xE0] ‘332’s claim 22 (same species of cancer)
Instant claim 38 [Wingdings font/0xE0] ‘332’s claim 25 (same method for preparing a stable aqueous pharmaceutical)
Instant claims 39, 40 [Wingdings font/0xE0] ‘332’s claim 26 (identical sequences)
Instant claims 41, 42 [Wingdings font/0xE0] ‘332’s claim 27 (identical sequences)
Instant claim 43 [Wingdings font/0xE0] ‘332’s claim 28 (same antibody)
Instant claim 44 [Wingdings font/0xE0] ‘332’s claim 29 (same kit for use)
Instant claim 45 [Wingdings font/0xE0] ‘332’s claim 30 (same article of manufacture)
Instant claim 46 [Wingdings font/0xE0] ‘332’s claim 31 (same article of manufacture)
Instant claim 47 [Wingdings font/0xE0] ‘332’s claim 32 (same article of manufacture)
Instant claim 54 [Wingdings font/0xE0] ‘332’s claim 33 (same method of reducing infusion-related reactions in a subject)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
Applicant argues that the Office has failed to establish that one of ordinary skill in the art would have arrived at the claimed subject matter from the cited reference. This is not found persuasive.
As discussed above, the co-pending application teaches the same antibody, in the same formulations, targeted towards the same diseases, that are administered in the same methods as instantly claimed. Applicant has not challenged how the instant claims differ from the co-pending application’s claims nor have the claims been amended to obviate the rejection. Thus, the instant claims continue to read on the copending application.
As such, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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