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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statement filed 29 Jan, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because one of the citations is incorrect. WO2021009228 does not match the citation, as the applicant is not the same as listed in the information disclosure statement. Thus, this reference was not considered.
Drawings
The drawings are objected to because fig 12A is lacking units on the X-axis. 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.
Election/Restrictions
Applicant’s election without traverse of treatment of a spinal cord injury with alpha 1 antitrypsin and no other elected therapeutic in the reply filed on 25 March, 2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Applicants have elected treating a spinal cord injury with no additional therapeutic. A search was conducted for this invention, and references rendering it obvious were found. As a result, claims 1, 6, 13, 15-17, 19, 21, 22, 25, and 65 were examined, and claims 2-5, 7-9, 11, 12, 45, and 64 have been withdrawn from consideration. Applicants have stated that they believe claims 2, 7-9, 11, 12, 45, and 64 read on their elected species, however, claims 2, 45, and 64 require limitations of the patient population that applicants have not elected, and claims 7-9, 11, and 12 require a second therapeutic, which applicants specifically did not elect. Thus, they are properly withdrawn.
Claims Status
Claims 1,2, 6-9, 11-13, 15-17, 19, 21, 22, 25, 45, 64, and 65 are pending.
Claims 2-5, 7-9, 11, 12, 45, and 64 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 25 March, 2026.
Claim Rejections - 35 USC § 112(b)
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.
first rejection
Claim 15 is 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.
Claim 15 requires a dose of between 80 mg/kg/day and 240 mg/kg/day per dose. These units do not appear to match what the claim is requiring. If it’s the total daily dosage, the units would be mg/kg/day. If it’s per dose, the units would be mg/kg.
second rejection
Claims 17 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 17 and 19 both describe a wide range and a narrow range, making it unclear which range is the actual claim limitation.
third rejection
Claims 1, 6, 13, 15-17, 19, 21, 22, 25, and 65 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.
Claim 1, and claims dependent on it, require administration of alpha 1 antitrypsin. Alpha 1 antitrypsin has not been defined, and it is not clear what the scope of this limitation is. Paragraph 20 allows for all wild type mammalian variants, with human preferred. But it also discusses derivatives and variants, which do not particularly limit the sequence of the polypeptide (paragraphs 22 and 23). It is not clear if the limitation “alpha 1 antitrypsin” encompasses these compounds.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 describes limitations of the dose and dose schedule, but those limitations are also found in claim 1, from which claim 13 depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 1, 6, 13, 15-17, 19, 21, 22, 25, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Nathan et al (US 2011023496, cited by applicants) with evidentiary support from Bellacen et al (Cell Transplant. (2013) 22 p2119-2133).
Nathan et al discuss the antinecrotic activity of alpha 1 antitrypsin (title), which can be used to treat spinal cord injury (paragraph 38), applicant’s elected disorder. Dosing can be about 75 to 150 mg/kg/day, or 20-500 mg/kg/day (paragraph 32) for several days to several weeks until the disease state is diminished (paragraph 121) (i.e. multiple dosage regimen). Dosing can be by nasal, intramuscular, subcutaneous, transdermal, parenteral, or combinations (paragraph 31).
While this reference discusses all the limitations of the examined claims, the ranges given overlap, but do not entirely match those of applicants, and some limitations are selected from various lists, making obviousness a better fit than anticipation (MPEP 2144.05(I)).
Nathan et al discusses alpha 1 antitrypsin to treat spinal cord injury (applicant’s elected disorder) at a dose overlapping with that claimed by applicants, in a multidose regimen, rendering obvious claims 1, 6, 13, 15, and 16.
Nathan et al suggests dosing for several days to several weeks, rendering obvious claims 17, 19, 21, and 22.
Nathan et al discuss IM, subQ, transdermal, and nasal administration, rendering obvious claim 25.
Claim 65 discusses the effect of the therapy, which will necessarily occur with the treatment of Nathan et al, rendering that claim obvious. Note that, as evidenced by Bellacen et al, alpha 1 antitrypsin is known to induce vascularization via VEGF (abstract); this is a known effect of the therapeutic as of applicant’s priority date.
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.
first rejection
Claims 1, 13, 15-17, 19, 21, 22, 25, and 65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 38, and 39 of copending Application No. 18/993,489 (US 20260022158) in view of Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
Competing claim 1 describes a method of treating stroke, a neural cell injury caused by a non-traumatic brain injury (note examined claim 3). Competing claim 39 specifies one of the therapeutics to be selected from a Markush group including alpha 1 antitrypsin. Competing claim 38 lists a number of administration routes that overlap with examined claim 25.
The difference between the competing claims and the examined claims is that the competing claims do not specify the dose or dose schedule.
Le Tourneau et al discuss the phase I clinical trial (title). The main goal of these studies is to establish the optimum dose and dose schedule for new drugs or drug combinations (abstract), to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual (p708, 1st column, 2nd paragraph). A number of protocols are given to accomplish such optimizations (note fig 2, p711, entire page, for example).
Therefore, it would be obvious to optimize the dose and dose schedule of the therapy of the competing claims, to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual, as described by Le Tourneau et al. As every drug used must have its dose and dose schedule optimized, a person of skill in the art would be familiar with these optimizations, leading to a reasonable expectation of success (MPEP 2144.05(II)(A)).
This is a provisional nonstatutory double patenting rejection.
second rejection
Claims 1, 13, 15-17, 19, 21, 22, and 65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of copending Application No. 18/004,233 (US 20230265167) in view of Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
Competing claim 1 describes a method of generating new neuronal cells in a Markush group of disorders, including spinal cord injury. Competing claim 10 specifies one of the therapeutics to be selected from a Markush group including alpha 1 antitrypsin.
The difference between the competing and the examined claims is that the competing claims do not specify the dose or dose schedule.
Le Tourneau et al discuss the phase I clinical trial (title). The main goal of these studies is to establish the optimum dose and dose schedule for new drugs or drug combinations (abstract), to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual (p708, 1st column, 2nd paragraph). A number of protocols are given to accomplish such optimizations (note fig 2, p711, entire page, for example).
Therefore, it would be obvious to optimize the dose and dose schedule of the therapy of the competing claims, to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual, as described by Le Tourneau et al. As every drug used must have its dose and dose schedule optimized, a person of skill in the art would be familiar with these optimizations, leading to a reasonable expectation of success (MPEP 2144.05(II)(A)).
This is a provisional nonstatutory double patenting rejection.
third rejection
Claims 1, 13, 15-17, 19, 21, 22, and 65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of copending Application No. 18/004,233 (US 20230263863) in view of Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
Competing claim 1 describes a method of generating new neuronal cells in a Markush group of disorders, including spinal cord injury. Competing claim 10 specifies one of the therapeutics to be selected from a Markush group including alpha 1 antitrypsin.
The difference between the competing and the examined claims is that the competing claims do not specify the dose or dose schedule.
Le Tourneau et al discuss the phase I clinical trial (title). The main goal of these studies is to establish the optimum dose and dose schedule for new drugs or drug combinations (abstract), to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual (p708, 1st column, 2nd paragraph). A number of protocols are given to accomplish such optimizations (note fig 2, p711, entire page, for example).
Therefore, it would be obvious to optimize the dose and dose schedule of the therapy of the competing claims, to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual, as described by Le Tourneau et al. As every drug used must have its dose and dose schedule optimized, a person of skill in the art would be familiar with these optimizations, leading to a reasonable expectation of success (MPEP 2144.05(II)(A)).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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