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 .
Amendments
In the reply filed 12/26/2025, Applicant has amended Claims 1, 4, 6, and 7.
Claims 2, 9, 12, 15-20, 25, 34, 39, and 64-65 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1, 4-7, 11 are under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/26/2025 was filed after the mailing date of the non-final Office action on 7/29/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objection to Drawings for Sequence Compliance
The prior objection to Figure 2B (Trem2 amino acid sequence) of the Specification as not conforming to sequence rules is withdrawn in light of the amended Drawings filed 12/26/2025.
Withdrawn Objection to the Specification for Sequence Compliance
The prior objection to the Specification as not conforming to sequence rules is withdrawn in light of the amended Specification filed 12/26/2025.
Withdrawn Claim Objections
The objection to Claim 4 is withdrawn due to Applicant’s amendment.
Withdrawn 35 USC § 112
The prior rejection of Claims 6 and 7 under 35 U.S.C. § 112(b) pre-AIA 2nd paragraph as being indefinite is withdrawn in light of Applicant’s amendments of instant claims to describe the polynucleotides.
Withdrawn 35 USC § 103
The prior rejection of Claims 1, 6, 7, and 11 under 35 U.S.C. 103 as being unpatentable over Mason et al., (US 2022/0133808, filed 1/31/2020, with priority to US 62/800,177, filed 2/01/2019), in view of Huang (Cell, 2017, 168:427-441, see IDS filed 2/27/2024) is withdrawn in light of Applicant’s amendment of Claim 1 to limit the expression vector cassette to further include MT1G, which is a limitation neither Mason nor Huang make obvious.
The prior rejection of Claim 4 under 35 U.S.C. 103 as being unpatentable over Mason et al., (US 2022/0133808, filed 1/31/2020, with priority to US 62/800,177, filed 2/01/2019), in view of Huang (Cell, 2017, 168:427-441, see IDS filed 2/27/2024), as applied to Claim 1, in further view of West (US 8,691,765, patented 4/08/2014) is withdrawn in light of Applicant’s amendment of Claim 1 to limit the expression vector cassette to further include MT1G, which is a limitation neither Mason, Huang nor West make obvious.
New 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 4-7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al., (US 2022/0133808, filed 1/31/2020, with priority to US 62/800,177, filed 2/01/2019), in view of Huang (Cell, 2017, 168:427-441, see IDS filed 2/27/2024), West (US 8,691,765, patented 4/08/2014, prior art of record), and Mehus et al. (Mol Cell Proteom, 2014, 13:1020-1033, prior art of record).
In regard to claim 1, Mason teaches methods of treating Alzheimer’s disease in a patient in need thereof, comprising providing to the patient one or more nucleic acid molecules that increase the expression of APOE and TREM2 proteins, wherein the one or more nucleic acid molecules are provided to patient by administering to the patient a composition of a therapeutically effective amount of cells that comprise an expression vector for the APOE and TREM2 proteins (see Claims 1, 22, 24, and 37, and Example 1, p.165, Example 4, p. 167 of priority document).
However, Mason is silent with respect to the APOE isoform being APOE2.
In regard to choosing APOE2, Huang et al. teach that the APOE2 isoform is neuroprotective in Alzheimer’s disease (Abstract).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice the method of treating Alzheimer’s comprising administering cells that express APOE and TREM2 as taught by Mason, and choose APOE2 as the isoform to express as taught by Huang with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Huang because the APOE2 isoform is the neuroprotective isoform against Alzheimer’s disease.
However, Mason is silent with respect to further including a nucleic acid encoding for metallothionein (MT).
In regard to combining a metallothionein gene, West et al. teach a method of treating Alzheimer’s comprising administering to the subject recombinant metallothionein, such as MTI and MTII (col 2, Statement of the Invention, 1st four para., col 3, 4th para., col 14, Table 1, and see claims 1 and 12 of West).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice the method of treating Alzheimer’s comprising administering cells that express APOE2 and TREM2 as suggested by Mason et al., and further combine nucleic acids to express recombinant metallothioneins MTI and MTII as taught by West with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by West because the inclusion of these metallothionein genes would promote neuronal survival and regeneration, and buffer again toxic metals implicated in the pathology of Alzheimer’s disease (Table 1 of West).
However, Mason et al. in view of West are silent with respect to the MT1 of MT1G.
Nevertheless, among the MT1 variants that could be used, Mehus teaches that the MT1G isoform is one of the few expressed in the brain. Furthermore, Mehus teaches that MT1G occurs in two splice variants MT1G1 and MT1G2 (p. 1023, Table 1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to practice the method of treating Alzheimer’s comprising administering cells that express APOE2 and TREM2 and metallothionein genes MT1 and MT2 as suggested by Mason, Huang in view of West, and choose expressing the MT1G splice variants expressed in the brain as taught by Mehus with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Mehus because MT1G is one the naturally occurring brain isoforms, thus it would have been obvious to use a brain isoform in order to treat a brain disease such as Alzheimer’s. Furthermore, since there was such a small genus of MT1 genes to choose from, one of ordinary skill in the art would had immediately envisioned this species from such a limited genus of options.
In regard to claims 4 and 5, as stated supra, it would have been obvious to use two copies of the MT1G gene so as to include both splice variants MT1G1 and MT1G2. Furthermore in regard to claim 5, duplicating the number of genes to be included in the vector for a total of four copies is obvious because the courts have held that a mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04VI(B) summarizes that although a prior art reference does not disclose a plurality of elements, the court held that “mere duplication of parts has no patentable significance unless a new and unexpected result is produced”, In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see also St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
In regard to claims 6 and 7, Mason teaches that the vector comprises a promoter such as PGK (see Claims 87-88, and p. 26, 3rd para., p. 37, last para., of priority document).
In regard to claim 11, Mason teaches that the vector is a lentiviral vector (see Claims 58 and 80, and Example 1, p.165, of priority document).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 12/26/2025 are acknowledged.
First, Applicant argues that Mason teaches dozens of potential genes that may be useful for treating AD, along with hundreds of panels. Applicant notes that Table 1 is silent to including APOE, let alone APOE and TREM2. Thus, Applicant argues that one of ordinary skill would not have had a reasonable expectation of success in picking the specific combination of APOE2 and TREM2 as claimed.
Second, Applicant argues that Mason, Huang, West, and Mehus fail to teach a cell therapy method for treating AD comprising APOE2, TREM2, and MT1G. Applicant argues that Mason and Huang are silent to MT1G, while West is directed to the MT superfamily to treat AD, of which West provides guidance for the MT2A isoform in the working examples, and is completely silent to MT1G, while Mehus only discloses that the MT1G isoform is expressed in the brain, and silent to using MT1G to treat AD.
Furthermore, Applicant argues that West fails to teach or suggest a cell therapy method, and teaches directly administrating the metallothionein to the neurons to treat AD. Thus, the West method of administration varies significantly in biological activity, biological properties, time-course compared to the claimed cell-based therapy. Thus, Applicant argues that one of ordinary skill would not have had sufficient guidance as to the therapeutic effects of APOE, TREM2, and MT1G to treat AD.
Applicant's arguments have been fully considered but they are not persuasive.
In response to Applicant’s first argument, although Mason does not provide a preferred embodiment of a cell therapy method to treat AD comprising a cell that overexpresses both TREM2 and a APOE, Mason does provide a prophetic embodiment of treating AD with pluripotent cells expressing one or more therapeutic proteins selected from TREM2 and APOE (see Example 4 of provisional), Mason also claims this combination for a method of treating AD (see Claim 1 of provisional, below).
[AltContent: textbox ([img-media_image1.png])]The MPEP 2123 (I) states that patents are relevant as prior art for all they contain, and that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. In instant case, the therapeutic genes to be included in the cell therapy as taught by Mason were typical agents found in the neurology art and appear both in the specification and in the claims. As acknowledged by Applicant, Mason specifically sets forth the use of TREM2 to treat AD in Table 1 (p.8 of priority document), provides the sequence encoding TREM2 in Table 5 (p. 103 of priority document) and also describes the role of TREM2 in AD and how its loss of function mutations are associated with AD (pgs. 52-54 of priority document). Thus, Applicant must admit that the disclosures of Mason make obvious choosing at least TREM2 from the limited genus of options put forth in the specification and claims of Mason, which axiomatically establishes a reasonably expectation of success in treating AD independent of how many other transgenes are combined. In regard to also choosing APOE2 for the combination, Mason does claim the use of the generic APOE, which was well known to include the APOE2 variant. Furthermore, as cited in the pending rejection, the prior art of Huang et al. teach that APOE2 isoform is neuroprotective in Alzheimer’s disease (Abstract). Thus, one of ordinary skill in the art would have immediately envisaged choosing APOE2 from the limited genus of APOE variants.
Furthermore, the fact that the prior art teaches these elements within lists of known options does not render their selection any less obvious. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“That the ʼ813 patent discloses a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose.”); see also In re Susi, 440 F.2d 442, 445 (CCPA 1971) (obviousness rejection affirmed where the disclosure of the prior art was “huge, but it undeniably include[d] at least some of the compounds recited in appellant’s generic claims and [was] of a class of chemicals to be used for the same purpose as appellant’s additives”); In re Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009) (“[W]here a skilled artisan merely pursues ‘known options’ from a ‘finite number of identified, predictable solutions,’ obviousness under § 103 arises.” (quoting KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)).
[AltContent: textbox ([img-media_image2.png])]In response to Applicant's second argument, a 35 U.S.C. § 103(a) based test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In instant case, Mason is directed to cell therapy methods to treat AD by overexpression of one or more therapeutic proteins in cells, and West makes obvious the metallothionines MT1/MT2A as therapeutic proteins to treat AD (see excerpt from Table 1 of West, adjacent). Contrary to Applicant’s assertion, one of ordinary skill in the art of cell and gene therapies and under the direction of Mason would have understood that administering lentiviral modified cells allows high efficiency, stable, and “long-term expression of the transgene” (p. 154, 2nd para. of Mason’s priority document), and this approach would have avoided the well-known problems of protein therapy wherein “MT-I/-II would yield greater neuroprotection and neurodegeneration if it were injected more frequently than the single application performed in the current study (of West)” (col 13, lines 20-22 of West).
In regard to choosing MT1, Applicant is reminded that the term "comprising" used to claim the transgenes in instant method is open-ended and allows for additional, unrecited elements in the claims. MPEP 2111.03 specifically sets forth that the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). Applicant fails to specifically exclude an expression vector that includes both MT1 and MT2A in either the claims or the specification. Accordingly, the patent document of West makes obvious to include a combination of MT1 and MT2A therapeutic transgenes with a reasonable expectation of success.
[AltContent: textbox ([img-media_image3.png])]Finally, in regard to choosing the MT1G species from the MT1 genus of metallothionine genes, as cited by the review of Mehus, there are only a handful of MT1 isoforms, and of those, MT1G is one of the few that is expressed in the brain (see excerpt from Table I of Mehus adjacent), thereby making this isoform obvious to choose in order to treat a brain disease such as Alzheimer’s. MPEP 2144.08. II. 4(a) states that a genus may be so small that, when considered in light of the totality of the circumstances, it anticipates/makes obvious the claimed species or subgenus. For example, it has been held that a prior art genus containing only 20 compounds and a limited number of variations in the generic chemical formula inherently anticipated a claimed species within the genus because “one skilled in [the] art would... envisage each member” of the genus. In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962) (emphasis in original).
For the reasons stated above, there would have been a reasonable expectation of success in choosing the combination of TREM2, APOE2, and MT1G (as well as MT2A) to treat a subject having or having a propensity to develop Alzheimer’s. Any conclusions of unpredictability have to be made in the context of this particular disease state, which encompasses subjects who may be in the pre-symptomatic or early stages of AD. Furthermore, the Federal Circuit would have found that the claims at issue would have been obvious, since there had been ample suggestion in the prior art that the taught method would have worked. Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient.
Withdrawn Double Patenting
The prior provisional rejection of Claims 1, 6-7, and 11 on the grounds of nonstatutory double patenting as being unpatentable over claims 12, 15 and 21 of copending Application No. 18/401,135, in view of Mason et al., (US 2022/0133808, filed 1/31/2020, with priority to US 62/800,177, filed 2/01/2019) is withdrawn in light of Applicant’s amendment of Claim 1 to limit the expression vector cassette to further include MT1G.
The prior provisional rejection of Claim 4 on the grounds of nonstatutory double patenting as being unpatentable over claims 12, 15 and 21 of copending Application No. 18/401,135, in view of Mason et al., (US 2022/0133808, filed 1/31/2020, with priority to US 62/800,177, filed 2/01/2019), as applied to Claim 1, in further view of West (US 8,691,765, patented 4/08/2014) is withdrawn in light of Applicant’s amendment of Claim 1 to limit the expression vector cassette to further include MT1G.
New 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 4-7, and 11 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 12, 15 and 21 of copending Application No. 18/401,135, in view of Mason et al., (US 2022/0133808, filed 1/31/2020, with priority to US 62/800,177, filed 2/01/2019) West (US 8,691,765, patented 4/08/2014) Mehus et al. (Mol Cell Proteom, 2014, 13:1020-1033).. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for treating a subject having or at risk for a neurodegenerative disease comprising administering a cell comprising a vector expressing APOE2 and TREM2 of cited application makes obvious the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the instant application claims are more specific to the type of neurodegenerative disease being Alzheimer’s.
Nevertheless, Mason et al. suggest cell therapy method of treating Alzheimer’s comprising administering a therapeutically effective amount of cells that comprise a vector expressing APOE and TREM2 (see Claims 1, 22, 24, and 37, and Example 1, p.165, Example 4, p. 167 of priority document).
Accordingly, it would have been obvious to have claimed a method of treating a neurodegenerative disease as claimed in cited application and do so in an Alzheimer’s subject as claimed by instant Application with a reasonable expectation of success. One of ordinary skill the art would have been motivated to do so because Mason teaches that Alzheimer’s patients are suitable subjects for this type of method.
However, cited application is silent with respect to further including a nucleic acid encoding for metallothionein.
In regard to combining a metallothionein gene, West et al. teach a method of treating Alzheimer’s comprising administering to the subject recombinant metallothionein, such as MTI and MTII (col 2, Statement of the Invention, 1st four para., col 3, 4th para., col 4, Table 1, and see claims 1 and 12 of West).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have claimed the method of treating Alzheimer’s comprising administering cells that express APOE2 and TREM2 as suggested by Mason et al., and further combine nucleic acids to express recombinant metallothioneins MTI and MTII as taught by West with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by West because the inclusion of these metallothionein genes would promote neuronal survival and regeneration, and buffer again toxic metals implicated in the pathology of Alzheimer’s disease (Table 1 of West).
However, cited application is silent with respect to a metallothionein such as MT1G.
Nevertheless, among the MT1 variants that could be used, Mehus teaches that the MT1G isoform is one of the few expressed in the brain. Furthermore, Mehus teaches that MT1G occurs in two splice variants MT1G1 and MT1G2 (p. 1023, Table 1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have claimed the method of treating Alzheimer’s comprising administering cells that express APOE2 and TREM2 and metallothionein genes MT1 and MTII as suggested by Mason et al., and choose expressing the MT1G splice variants in the brain as taught by Mehus with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Mehus because MT1G is one the naturally occurring brain isoforms, thus it would have been obvious to use a brain isoform in order to treat a brain disease such as Alzheimer’s. Furthermore, since there was such a small genus of MT1 genes to choose from, one of ordinary skill in the art would had immediately envisioned this species from such a limited genus of options.
In regard to claims 4 and 5, using two and four copies, as stated supra, it would have been obvious to claim two copies of the MT1G gene so as to include both splice variants MT1G1 and MT1G2. Furthermore, duplicating the number of genes to be included in the vector is obvious because the courts have held that a mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04VI(B) summarizes that although a prior art reference does not disclose a plurality of elements, the court held that “mere duplication of parts has no patentable significance unless a new and unexpected result is produced”, In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see also St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
In regard to claims 6 and 7, Mason teaches that the vector comprises a promoter such as PGK (see Claims 87-88, and p. 26, 3rd para., p. 37, last para., of priority document), and one of ordinary skill in the art would have claimed such a promoter in order to ensure ubiquitous expression of the genes.
In regard to claim 11, Mason teaches that the vector is a lentiviral vector proteins (see Claims 58 and 80, and Example 1, p.165, of priority document), and one of ordinary skill in the art would have claimed such a vector because of its clinical relevance in modifying cells for human diseases.
Since the instant application claims are obvious over cited application claims in view of Mason, West, and Mehus, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 12/26/2025 are acknowledged, and ask that instant rejection be held in abeyance.
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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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