DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
1. Claims 24-26 and 28-36 are pending and subject to examination on the merits. Claims 28-30 are withdrawn from consideration as being drawn to non-elected subject matter. Claims 24-26 and 31-36 are currently under examination.
Election/Restrictions
2. Applicant's election with traverse of group I, claims 24-26 and 31-36, in the reply filed on 02 April 2026 is acknowledged. The traversal is on the ground(s) that the examination of both groups of claims would not be overly burdensome to the examiner. This is not found persuasive because the two groups of inventions have separate status in the art in view of their different classification, where each group would require a separate and distinct keyword search, specifically group I is classified under C12N9/2474 and group II is classified under A61P35/00.
The requirement is still deemed proper and is therefore made FINAL.
Priority
3. Acknowledgment is made for the Applicant’s claim for domestic priority based on the US provisional application PRO 61/631,313 filed 30 December 2011.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on 22 October 2024 and 18 December 2024 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Drawings
5. The drawings are objected to because there is reference to SEQIDNO_3, SEQIDNO_10_ in Fig 2A, SEQIDNO_3 and SEQIDNO_12_ in Fig. 2B, SEQIDNO_3 and SEQIDNO_14_ in Fig. 2C, SEQIDNO_3 and SEQIDNO_16_ in Fig. 2D, SEQIDNO_3 and SEQIDNO_20_ in Fig. 2E, SEQIDNO_3 and SEQIDNO_22_ in Fig. 2F, SEQIDNO_3 and SEQIDNO_24_ in Fig. 2G, SEQIDNO_3 and SEQIDNO_29_ in Fig. 2H, SEQIDNO_3 in Fig. 2I, SEQIDNO_3 and SEQIDNO_857 in Fig. 2J, SEQIDNO_3 and SEQIDNO_859 in Fig. 2K, SEQIDNO_3 and SEQIDNO_861 in Fig. 2L do not conform to the sequence rules. The identifier should be written as SEQ ID NO:. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
6. Claim 35 is objected to because of the following informalities: “of amino acid sequence of SEQ ID NO: 3” should be amended to “of SEQ ID NO: 3” to improve grammar. Appropriate correction is required.
7. Claim 36 is objected to because of the following informalities: “of amino acid sequence of SEQ ID NO: 3” should be amended to “of SEQ ID NO: 3” to improve grammar. Appropriate correction is required.
Claim Rejections - 35 USC § 101
8. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
9. Claims 24, 32, and 34-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without additional elements that integrate the judicial exception into a practical application. An analysis with respect to the claims as a whole reveals that they do not include additional elements that integrate the judicial exception into a practical application. See MPEP 2106.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
Step (1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
Step (Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
Step (Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
Step (2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG)).
Step 1: Yes; the claims are directed to a composition of matter.
Step 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a naturally occurring amino acid sequence.
Step 2A – Prong 2: No, the claims do not recite any additional elements that integrate the judicial exception into a practical application because the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites “at least 95%” which is inclusive a sequence 100% identical to the recited naturally occurring sequence.
Step 2B: As noted in answering that of 2A – This judicial exception is not integrated into a practical application because although there is a modification and percent homology recited, the phrasing “at least” includes a sequence that is 100% identical to the sequence found in nature. To overcome this rejection, delete the phrase “at least.”
Claim Rejections - 35 USC § 112(a)
10. 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.
Written Description:
11. Claims 24-26 and 31-36 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 claims are drawn to a pharmaceutical composition comprising: (a) an amino acid sequence, wherein: (i) at least 95% of the residues of the amino acid sequence are identical to the amino acid sequence selected from the group consisting of SEQ ID NOs: 3 and 32-66; (ii) the amino acid sequence comprises an amino acid modification at position 320; (iii) the modification at position 320 is E, G, H, I, K, M, N, R, S, W, Y, L, C, P, and V; and (b) a therapeutically active agent; wherein (a) and (b) are formulated for administration in the same composition.
MPEP 2163(1):
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en bane); Vas-Gath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim's enablement is not equally conclusive of that claim's satisfactory written description"). The written description requirement has several policy objectives. "[T]he 'essential goal' of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Gath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
12. The claims are drawn to a pharmaceutical composition comprising: (a) an amino acid sequence, wherein: (i) at least 95% of the residues of the amino acid sequence are identical to the amino acid sequence selected from the group consisting of SEQ ID NOs: 3 and 32-66; (ii) the amino acid sequence comprises an amino acid modification at position 320; (iii) the modification at position 320 is E, G, H, I, K, M, N, R, S, W, Y, L, C, P, and V; and (b) a therapeutically active agent; wherein (a) and (b) are formulated for administration in the same composition.
The variability in possible functions of the amino acids claimed is enormous, since no specific function is in the claim. The specification does not describe every possible function of these amino acid sequences. At most the specification describes modified PH20 hyaluronidase polypeptides, not any other possible amino acid sequence function. Here the specification is incomplete and it mandates that those skilled in the art must then figure out how to use the aimed invention. Thus, the claims do not find adequate support in any place in the specification to show that possession of any function that could possibly be attributed to the amino acid sequences. The courts have established:
Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013):
A patent, however, "is not a reward for the search, but compensation for its successful conclusion." Ariad, 598 F.3d at 1353 (quoting University of Rochester, 358 F.3d at 930 n.10). For that reason, the written description requirement prohibits a patentee from "leaving it to the ... industry to complete an ufinished invention.” Id.
Enablement:
13. Claims 24-26 and 31-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for modified PH20 hyaluronidase polypeptides, does not reasonably provide enablement for all possible functions that could be attributed to the recited amino acid sequences. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims without significant undue experimentation.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states:
"Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The claims in their broadest are drawn to a pharmaceutical composition comprising: (a) an amino acid sequence, wherein: (i) at least 95% of the residues of the amino acid sequence are identical to the amino acid sequence selected from the group consisting of SEQ ID NOs: 3 and 32-66; (ii) the amino acid sequence comprises an amino acid modification at position 320; (iii) the modification at position 320 is E, G, H, I, K, M, N, R, S, W, Y, L, C, P, and V; and (b) a therapeutically active agent; wherein (a) and (b) are formulated for administration in the same composition. The direction and guidance coupled with the working examples of the application, however, are drawn only to modification of PH20 hyaluronidase polypeptides, not any other possible function of the recited amino acid absent a recited function. The quantity of experimentation would be considerable because, while the relative skill level in the art is high (PhD or MD), they would be required to ascertain the function of the amino acid sequence without any guidance as to what that function is. It would be extremely difficult to discern a function for an amino acid sequence without any guidance, i.e. what type of polypeptide it encodes.
Enablement:
14. Claim 34 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for modified PH20 hyaluronidase polypeptides, does not reasonably provide enablement for all possible functions that could be attributed to the recited amino acid sequences absent hyaluronidase activity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims without significant undue experimentation.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states:
"Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The claim in its broadest is drawn to a pharmaceutical composition comprising: (a) an amino acid sequence, wherein: (i) at least 95% of the residues of the amino acid sequence are identical to the amino acid sequence selected from the group consisting of SEQ ID NOs: 3 and 32-66; (ii) the amino acid sequence comprises an amino acid modification at position 320; (iii) the modification at position 320 is E, G, H, I, K, M, N, R, S, W, Y, L, C, P, and V; and (b) a therapeutically active agent; wherein (a) and (b) are formulated for administration in the same composition, and wherein said amino acid sequence does not exhibit hyaluronidase activity. The direction and guidance coupled with the working examples of the application, however, are drawn only to modification of PH20 hyaluronidase polypeptides, not any other possible function of the recited amino acid absent the recited absence of hyaluronidase activity. The quantity of experimentation would be considerable because, while the relative skill level in the art is high (PhD or MD), they would be required to ascertain the function of the amino acid sequence without any guidance as to what that function is. It would be extremely difficult to discern a function for an amino acid sequence without any guidance, i.e. what type of polypeptide it encodes.
Claim Rejections - 35 USC § 112b
15. 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.
16. Claims 24-26 and 31-36 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.
17. Claim 24 recites the limitation "the amino acid sequence" in (i) line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear which instance of “an amino acid sequence” this limitation is drawn to, since there are two preceding it, specifically at (a) and at (i) line 2. Claims 25-26 and 31-36 are included in the rejection, since they do not mitigate the issue.
18. Claim 25 recites the limitation “the therapeutically active agent is a polypeptide, a protein.” There is insufficient antecedent basis for this limitation in the claim because it is unclear if the therapeutic agent polypeptide and/or protein is the polypeptide/protein recited in parts i-ii of claim 24 or if it is an entirely different protein or polypeptide.
19. Claim 32 recites the limitation "the amino acid sequence" in (i) line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear which instance of “an amino acid sequence” this limitation is drawn to, since there are two preceding it, specifically at (a) and at (i) line 2 in claim 24.
20. Claim 34 recites the limitation "the amino acid sequence" in (i) line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear which instance of “an amino acid sequence” this limitation is drawn to, since there are two preceding it, specifically at (a) and at (i) line 2 in claim 24.
21. Claim 35 recites the limitation "the amino acid sequence" in (i) line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear which instance of “an amino acid sequence” this limitation is drawn to, since there are two preceding it, specifically at (a) and at (i) line 2 in claim 24.
22. Claim 35 recites the limitation “amino acid sequence results in a structure that has increased hyaluronidase activity.” However, there is no reference to hyaluronidase activity to the polypeptides in claim 24.
23. Claim 36 recites the limitation "the amino acid sequence" in (i) line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear which instance of “an amino acid sequence” this limitation is drawn to, since there are two preceding it, specifically at (a) and at (i) line 2 in claim 24.
24. Claim 36 recites the limitation “amino acid sequence results in a structure that has decreased hyaluronidase activity.” However, there is no reference to hyaluronidase activity to the polypeptides in claim 24.
Double Patenting
25. 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) 7 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.
26. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 35 of copending Application No. 19/071,345 (reference application) and as evidenced by Kumar et al (Kumar et al., 2024, 3 Biotech—cited herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent. Position 320 corresponds to amino acid 355 of the polypeptide in the ‘345 application.
The claims of the ‘345 application in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of amino acids 38-340 of SEQ ID NO: 6 and mutations at amino acids 341 and 355.
It is noted that SEQ ID NO: 3 of the instant application and SEQ ID NO: 6 of the ‘345 application are identical after amino acid 36 of SEQ ID NO: 6.
Therefore, the only difference is the requirement of the instant polypeptide to include a pharmaceutical composition. However, even with this requirement, the ‘345 claims would still anticipate the instant claims because recombinant polypeptides can act as a therapeutics and pharmaceutical compositions as evidenced by Kumar et al. (Introduction, paragraph 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
27. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-36 and 55 of copending Application No. 19/071,264 (reference application) and as evidenced by Kumar et al (Kumar et al., 2024, 3 Biotech—cited herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘264 application in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of amino acids 38-468 of SEQ ID NO: 6 and mutations at a number of amino acid positions, including amino acid 320 (of the instant claims), corresponding to amino acid 355 of the ‘264 application.
It is noted that SEQ ID NO: 3 of the instant application and SEQ ID NO: 6 of the ‘264 application are identical after amino acid 36.
Therefore, the only difference is the requirement of the instant polypeptide to include a pharmaceutical composition. However, even with this requirement, the ‘264 claims would still anticipate the instant claims because recombinant polypeptides can act as a therapeutics and pharmaceutical compositions as evidenced by Kumar et al. (Introduction, paragraph 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
28. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-45, 64-66, and 68-73 of copending Application No. 19/071,092 (reference application) and as evidenced by Kumar et al (Kumar et al., 2024, 3 Biotech—cited herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘092 application in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of amino acids 38-468 of SEQ ID NO: 6 and mutations at a number of amino acid positions, including amino acid 320 (of the instant claims), corresponding to amino acid 355 of the ‘092 application.
It is noted that SEQ ID NO: 3 of the instant application and SEQ ID NO: 6 of the ‘092 application are identical after amino acid 36.
Therefore, the only difference is the requirement of the instant polypeptide to include a pharmaceutical composition. However, even with this requirement, the ‘092 claims would still anticipate the instant claims because recombinant polypeptides can act as a therapeutics and pharmaceutical compositions as evidenced by Kumar et al. (Introduction, paragraph 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
29. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 25, and 31-36 of copending Application No. 19/550,132 (reference application) and as evidenced by Kumar et al (Kumar et al., 2024, 3 Biotech—cited herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘132 application in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of amino acids 3-433 of SEQ ID NO: 35 and mutations at a number of amino acid positions, including amino acid 320 (where SEQ ID NO: 35 of the ‘132 application and SEQ ID NO: 3 of the instant application are identical from amino acids 1-433).
Therefore, the only difference is the requirement of the instant polypeptide to include a pharmaceutical composition. However, even with this requirement, the ‘132 claims would still anticipate the instant claims because recombinant polypeptides can act as a therapeutics and pharmaceutical compositions as evidenced by Kumar et al. (Introduction, paragraph 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
30. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-45, 64-66, and 68-73 of copending Application No. 19/071,092 (reference application) and as evidenced by Kumar et al (Kumar et al., 2024, 3 Biotech—cited herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘092 application in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of amino acids 38-468 of SEQ ID NO: 6 and mutations at a number of amino acid positions, including amino acid 320 (of the instant claims), corresponding to amino acid 355 of the ‘092 application.
It is noted that SEQ ID NO: 3 of the instant application and SEQ ID NO: 6 of the ‘092 application are identical after amino acid 36.
Therefore, the only difference is the requirement of the instant polypeptide to include a pharmaceutical composition. However, even with this requirement, the ‘092 claims would still anticipate the instant claims because recombinant polypeptides can act as a therapeutics and pharmaceutical compositions as evidenced by Kumar et al. (Introduction, paragraph 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
31. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 25, 27, 29-37 of copending Application No. 19/551,393 (reference application) and as evidenced by Kumar et al (Kumar et al., 2024, 3 Biotech—cited herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘393 application in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of amino acids 38-468 of SEQ ID NO: 6 and mutations at a number of amino acid positions, including amino acid 320 (of the instant claims), corresponding to amino acid 355 of the ‘393 application.
It is noted that SEQ ID NO: 3 of the instant application and SEQ ID NO: 6 of the ‘393 application are identical after amino acid 36.
Therefore, the only difference is the requirement of the instant polypeptide to include a pharmaceutical composition. However, even with this requirement, the ‘393 claims would still anticipate the instant claims because recombinant polypeptides can act as a therapeutics and pharmaceutical compositions as evidenced by Kumar et al. (Introduction, paragraph 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
32. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 25, 27-28, 31, and 34-37 of copending Application No. 19/550,136 (reference application) and as evidenced by Kumar et al (Kumar et al., 2024, 3 Biotech—cited herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘136 application in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of amino acids 38-468 of SEQ ID NO: 6 and mutations at a number of amino acid positions, including amino acid 320 (of the instant claims), corresponding to amino acid 355 of the ‘136 application.
It is noted that SEQ ID NO: 3 of the instant application and SEQ ID NO: 6 of the ‘136 application are identical after amino acid 36.
Therefore, the only difference is the requirement of the instant polypeptide to include a pharmaceutical composition. However, even with this requirement, the ‘136 claims would still anticipate the instant claims because recombinant polypeptides can act as a therapeutics and pharmaceutical compositions as evidenced by Kumar et al. (Introduction, paragraph 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
33. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-36, 55-61, 63, and 65-66 of copending Application No. 19/071,055 (reference application) and as evidenced by Kumar et al (Kumar et al., 2024, 3 Biotech—cited herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘055 application in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of amino acids 38-468 of SEQ ID NO: 6 and mutations at a number of amino acid positions, including amino acid 320 (of the instant claims), corresponding to amino acid 355 of the ‘055 application.
It is noted that SEQ ID NO: 3 of the instant application and SEQ ID NO: 6 of the ‘055 application are identical after amino acid 36.
Therefore, the only difference is the requirement of the instant polypeptide to include a pharmaceutical composition. However, even with this requirement, the ‘055 claims would still anticipate the instant claims because recombinant polypeptides can act as a therapeutics and pharmaceutical compositions as evidenced by Kumar et al. (Introduction, paragraph 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
34. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13-14, 19, 23, and 27 of U.S. Patent No. 10865400. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘400 patent in their broadest are drawn to a modified PH20 polypeptide and pharmaceutical composition thereof comprising a substitution at a number of positions, including amino acid 320.
Therefore, the only difference is that the ‘400 claims comprise a multitude of possible amino acid substitutions, whereas the instant claims comprise a single mutation at 320. However, the ‘400 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
35. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, 12, and 21 of U.S. Patent No. 11041149. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘149 patent in their broadest are drawn to a modified PH20 polypeptide and pharmaceutical composition thereof comprising a substitution mutation at amino acid 309.
Therefore, the only difference is that the ‘149 claims comprise a multitude of possible amino acid substitutions, whereas the instant claims comprise a single mutation at 320.
However, the ‘149 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
36. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 14-18 of U.S. Patent No. 11952600. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘600 patent in their broadest are drawn to a modified PH20 polypeptide and pharmaceutical composition thereof comprising a substitution mutation at amino acid 320.
Therefore, the only difference is that the ‘600 claims comprise 4 possible amino acid substitutions at position 320, specifically a H, K, R, and S, whereas the instant claims comprise 15 possible amino acid substitutions, specifically E, G, H, I, K, M, N, R, S, W, Y, L, C, P, and V.
However, the ‘600 claims will still anticipate the instant claims, since amino acid substitutions of H, K, R, and S overlap with the amino acid possibilities of the instant claims.
37. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, 12, and 21 of U.S. Patent No. 12037618. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘618 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3, 7, and 32-66 with at least 91% sequence identity, and wherein at least one mutation at amino acid 309.
Therefore, the only difference is that the ‘618 claims comprises an amino acid mutation at position 309, whereas the instant claims comprise a single mutation at 320.
However, the ‘618 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
38. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 8, 10-15, 24-27, and 29-30 of U.S. Patent No. 12123035. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘035 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3, 7, and 32-66 with at least 91% sequence identity, and wherein at least one mutation at amino acid 312.
Therefore, the only difference is that the ‘035 claims comprises an amino acid mutation at position 312, whereas the instant claims comprise a single mutation at 320.
However, the ‘035 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
39. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-27, 31-32, and 36 of U.S. Patent No. 12195773. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘773 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NO: 3 with at least one mutation at amino acid 320, wherein the amino acid mutation is H, K, or R.
Therefore, the only difference is that the ‘773 claims comprise 3 possible amino acid substitutions at position 320, specifically a H, K, and R, whereas the instant claims comprise 15 possible amino acid substitutions, specifically E, G, H, I, K, M, N, R, S, W, Y, L, C, P, and V.
However, the ‘773 claims will still anticipate the instant claims, since amino acid substitutions of H, K, R, and S overlap with the amino acid possibilities of the instant claims.
40. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 14-15, and 17 of U.S. Patent No. 12077791. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘791 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3 and 35 with at least 95% sequence identity, and wherein at least one mutation at amino acid 309.
Therefore, the only difference is that the ‘791 claims comprises an amino acid mutation at position 309, whereas the instant claims comprise a single mutation at 320.
However, the ‘791 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
41. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-15, 24-27, and 29-30 of U.S. Patent No. 12123035. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘035 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3, 7 and 32-66 with at least 91% sequence identity, and wherein at least one mutation at amino acid 312.
Therefore, the only difference is that the ‘035 claims comprises an amino acid mutation at position 324, whereas the instant claims comprise a single mutation at 312.
However, the ‘035 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
42. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-14, 16, 24, 26-27, 29-30, and 32-33 of U.S. Patent No. 12091692. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘035 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3, 7 and 32-66 with at least 91% sequence identity, and wherein at least one mutation at amino acid 313.
Therefore, the only difference is that the ‘692 claims comprises an amino acid mutation at position 313, whereas the instant claims comprise a single mutation at 320.
However, the ‘692 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
43. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-15, 24-27, and 29-30 of U.S. Patent No. 12060590. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘590 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3, 7 and 32-66 with at least 91% sequence identity, and wherein at least one mutation at amino acid 307.
Therefore, the only difference is that the ‘590 claims comprises an amino acid mutation at position 307, whereas the instant claims comprise a single mutation at 320.
However, the ‘590 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
44. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-14, 24-27, and 29-30 of U.S. Patent No. 12054758. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘758 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3, 7 and 32-66 with at least 91% sequence identity, and wherein at least one mutation at amino acid 317.
Therefore, the only difference is that the ‘758 claims comprises an amino acid mutation at position 317, whereas the instant claims comprise a single mutation at 320.
However, the ‘758 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
45. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 14, and 15 of U.S. Patent No. 12018298. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘298 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3, 7 and 32-66 with at least 91% sequence identity, and wherein at least one mutation at amino acid 313.
Therefore, the only difference is that the ‘298 claims comprises an amino acid mutation at position 313, whereas the instant claims comprise a single mutation at 320.
However, the ‘298 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
46. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 14-15, and 17 of U.S. Patent No. 12152262. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘262 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3, 7 and 32-66 with at least 91% sequence identity, and wherein at least one mutation at amino acid 317.
Therefore, the only difference is that the ‘262 claims comprises an amino acid mutation at position 317, whereas the instant claims comprise a single mutation at 320.
However, the ‘262 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
47. Claims 24-26 and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 37, 49-50, and 52-55 of U.S. Patent No. 12264345. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims in the broadest are drawn to a modified polypeptide relative to amino acids 1-433 of SEQ ID NO: 3, where amino acid 320 is modified, and a therapeutically active agent.
The claims of the ‘345 patent in their broadest are drawn to a modified polypeptide comprising an amino acid sequence of SEQ ID NOs: 3, 7 and 32-66 with at least 91% sequence identity, and wherein at least one mutation at amino acid 313.
Therefore, the only difference is that the ‘345 claims comprises an amino acid mutation at position 313, whereas the instant claims comprise a single mutation at 320.
However, the ‘345 claims will still anticipate the instant claims, since the instant claims are written with the “open” language comprising, where specifically “comprising” is utilized, allowing for other amino acid substitution mutations.
Conclusion
48. All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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