DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 7/13/26 is acknowledged. The traversal is on the ground(s) that the restriction between groups I and II do not meet the standard for restriction. This is not found persuasive for the reasons set forth in the restriction requirement mailed 5/20/26 establishing the lack of unity.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-17, 25-28 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/20/26.
Based on applicant’s amendments to Group III, the restriction requirement between groups II and III is withdrawn.
Claims 18-24, and 29-32 are under examination herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 6/18/24 and 7/13/26 have been fully considered except where references have been lined through.
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 19-22 and 29-32 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.
Regarding claims 19-22 and 29-32, the claims are directed to a product and a process of using the product, and it is unclear how the process language further limits the product. This is indefinite, see MPEP 2173.05(p) II.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Donati (WO2009016515).
Regarding claim 18, Donati teaches a 98% match to claimed SEQ ID NO 10 (appendix). Donati teaches that conservative substitutions can be made to their polypeptides (p90 first full paragraph). Therefore, it is prima facia obvious to one of ordinary skill in the arts to experiment with conservative substitutions in the polypeptide of Donati to arrive at a 99.5% match to claimed SEQ ID NO 10 (hyaluronidase is a well-known enzyme (see search results), and it would have been obvious to compare/align hyaluronidase sequences to identify candidate sites in the sequence of Donati for conservative substitution). Claim 18 does not require that the sequence variants encompassed by the claim have the properties of the enzyme of SEQ ID 10.
Adding limitations regarding the functionality/activity of the claimed modified polypeptide and/or an affidavit of unexpected results commensurate in scope with the claims could help to overcome this rejection.
Claims 19-24 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Donati (WO2009016515) as applied to claim 18 above, and further in view of Seifter ("Effect of hyaluronidase on experimental hypercholesterolemia in rabbits and rats and atheromatosis in rabbits." Proceedings of the Society for Experimental Biology and Medicine 83.3 (1953): 468-473) and Nohara ("Homozygous familial hypercholesterolemia." Journal of atherosclerosis and thrombosis 28.7 (2021): 665-678)
Regarding claims 19, 23-24, and 29 Donati teaches the composition can comprise pharmaceutical excipients (p91 “Immunogenic compositions and medicaments” section). Donati teaches the composition should contain an effective amount of the peptide (p107 2nd full paragraph).
Donati does not explicitly teach the use of the hyaluronidase to treat homozygous familial hypercholesterolemia.
Seifter teaches the effects of hyaluronidase on hypercholesterolemia (title). Seifter teaches that administration of hyaluronidase reduces hypercholesterolemia (discussion).
Donati and Seifter do not explicitly teach homozygous familial hypercholesterolemia.
Nohara teaches homozygous familial hypercholesterolemia (title). Nohara teaches aggressive therapy should be started as soon as possible (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the hyaluronidase of Donati to treat homozygous familial hypercholesterolemia as taught by Donati and Seifter. One of ordinary skill in the art would be motivated to do so because Donati teaches that hyaluronidase is effective against hypercholesterolemia and Nohara teaches that treatment against homozygous familial hypercholesterolemia needs to be started soon. There would be a reasonable expectation of success as Donati, Seifter and Nohara are in the same field of endeavor of treatments.
Regarding claim 20, Donati teaches that the amount of the treatment varies depending on a wide range of factors (p107 second full paragraph). Therefore, the amount of units administered is a result effective variable and one of ordinary skill in the arts is motivated to experiment with amounts to arrive at an effective treatment.
Regarding claim 21, Donati teaches the treatment can be solid (p106 last partial paragraph).
Regarding claim 22, Donati teaches the treatment can be intravenous (p109 4th full paragraph).
Regarding claims 30-32, Donati teaches the treatment can be administered to a mammal (subject) (p108 1st full paragraph).
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 18-24 and 29-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-9, and 11 of U.S. Patent No. 12,662,664B2 (formerly application 17/920,348). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 18 requires a 99.5 or more % match to SEQ ID 10. Claim 1 of ‘664 requires SEQ ID NO 1. These are identical sequences (appendix).
Regarding instant claims 19, 23-24, and 29-32 ‘664 claims 6 and 11 require a pharmaceutical composition comprising the peptide with pharmaceutically acceptable excipients and used to treat homozygous familial hypercholesterolemia.
Regarding instant claim 20, ‘664 claim 7 requires identical dosages.
Regarding instant claim 21, ‘664 claim 8 requires solid application.
Regarding instant claim 22, ‘664 claim 9 requires intravenous application.
Claims 18-21, 23-24, 29-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 20, 23-24 and 30 of copending Application No. 18/703,309 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 15 of ‘309 requires SEQ ID NO 10, this is an identical SEQ ID to instant claim 18 SEQ ID NO 10.
Regarding instant claims 19, 23-24, and 29-31 ‘309 claims 20 and 24 require a pharmaceutical composition comprising the peptide with pharmaceutically acceptable excipients and used to treat homozygous familial hypercholesterolemia.
Regarding instant claim 20, ‘309 claim 30 requires identical dosages.
Regarding instant claim 21, ‘309 claim 23 requires solid application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
