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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/13/2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of the species of Alzheimer’s disease and embryonic stem cells in the reply filed on 4/15/2025 is acknowledged. Upon further consideration, all species requirements are withdrawn.
Claims 19 and 26 are under consideration in the instant Office Action.
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.
Claims 19 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kido US 2012/0177614 (IDS 8/9/20222) in view of Kim et al., 2012 (IDS, 8/9/2022, CZ).
The instantly claimed method is towards the treatment of Alzheimer’s with the administration of a composition containing PSA-NCAM positive neural precursor cells.
Kido teaches using isolated expandable human neural cells to treat conditions caused by a loss of myelin or loss of oligodendrocytes which include treating Alzheimer’s’ disease (see Kido’s claims 34-37) as in instant claim 19. Kido teaches that neural precursor cells which include HFSC, and neuronal-restricted precursor (NPR) cells are PSA-NCAM positive (see Figure 2, paragraphs 14, 47, 121, 124-125, 131) and reads on instant claim 19. Kido teaches administering the human neural cells in a subject via intraventricular injection (see Kido’s claim 40). Kido fails to address the limitation of instant claim 19 wherein the PSA-NCAM-positive neural precursor cells are derived from neural rosettes differentiated from pluripotent stem cells.
Kim teaches producing PSA-NCAM positive neural precursors cells (NPCs; neural progenitor cells aka neural precursor cells) from human pluripotent stem cells such as human embryonic stem cells for cell replacement therapies of the nervous system (see page 1, 1st column and abstract) as in instant claims 19 and 26. Kim teaches that PSA-NCAM is expressed in neural cells and detecting PSA-NCAM expression in neural rosette cells during neural differentiation of hESCs and using PSA-NCAM as a marker for isolating primitive NPCs (see page 2, 1st column, 2nd paragraph) as in instant claim 26. Kim teaches this marker, PSA-NCAM, also allows the enrichment of a homogenous population of primitive NPC from hPSC (see page 4, 2nd column, 1st paragraph) and minimizes the concerns of tumorigenesis after transplantation (see page 2, 1st column, bottom of 2nd paragraph). Kim teaches that selecting the PSA-NCAM positive cells helps produce a homogenous population of cells and excludes neural crest cells (see page 4, 2nd column bottom of 1st paragraph, page 10, bottom of 1st and 2nd column). Kim teaches that the PSA-NCAM positive NPCs are able to integrate into the adult mammalian brain, have full capacity of neural differentiation potential in vivo and have a significantly lower possibility of neural outgrowth when compared to unsorted and non-propagated neural rosette cells (see page 8, bottom of 2nd column). Kim teaches using these PSA-NCAM positive NPCs as reliable cell source for future cell replacement therapy as cell therapy for neurodegenerative disorders. Kim does not specifically teach using these specific cells for specifically treating Alzheimer’s disease subjects.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Kido and Kim. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because one of ordinary skill in the art would want to administer a cell population able to produce neuronal cells to replace the lost cells due neuroinflammation diseases like Alzheimer’s without fear of leading to unwanted tumorigenesis. Kim teaches that one of the issues with NPCs is the potential of tumorigenesis (see page 2, 1st column). Further, one would be motivated to use the cells taught by Kido and Kim in the method of treatment of Alzheimer’s diseases since these cells are capable of integrating into the cortex and produce neurons as taught by Kim (see page 8, bottom of 2nd column) and Kido teaches using these cells in Alzheimer’s disease (see Kido’s claim 37). One of ordinary skill would be motivated to use these PSA-NCAM positive cells to treat neuroinflammatory diseases including Alzheimer’s disease since Kim teaches that these PSA-NCAM cells have the potential for promoting brain repair. Accordingly, the cumulative reference teachings render obvious the claimed method. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Therefore, claims 19 and 26 are obvious over Kido and Kim.
Response to Arguments
Applicant's arguments filed 8/13/2026 have been fully considered but they are not persuasive. Applicant argues that the references of record fail to motivate one of ordinary skill to combine the teachings of Kido and Kim and that there is no reasonable expectation of success. This is not found persuasive because all of the required limitations of the instant claims are disclosed or obvious over the references of record. The references presented and discussed above speak to the fact that the required treatment and the required patient population has been contemplated in the art. Kido clearly teaches using isolated expandable human neural cells to treat conditions caused by a loss of myelin or loss of oligodendrocytes which include treating Alzheimer’s’ disease (see Kido’s claims 34-37). Kim teaches producing PSA-NCAM positive neural precursors cells from human pluripotent stem cells such as human embryonic stem cells for cell replacement therapies of the nervous system (see page 1, 1st column and abstract). These references teach all of the required elements of the instant claims. They teach the specifically required cells, PSA-NCAM positive neural precursors cells, and using them in a subject to treat Alzheimer’s disease, a neurodegenerative disease. The prior art also teaches the methods necessary to produce and isolate the required cells. Therefore, all of the required elements were known in the prior art and not obtained from applicant’s disclosure.
While the references are silent on the intended results in the instant claim 19, such as the administration suppresses neuroinflammation associated with Alzheimer's disease by inhibiting activation of glial cells or astrocytes in the brain of the subject, the references teach the required poly-sialylated neural cell adhesion molecule (PSA-NCAM)-positive neural precursor cells to treat the same patient population. Therefore, the neural precursor cells will produce the same results as the instantly claimed method since one is practicing the active steps, administering the same neural precursor cells to the same patient population. MPEP 2145(II) states: “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)” (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).
MPEP 2112.02 states when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. The court went on to reverse the obviousness rejection of claims 2-5 and 7-10 which recited a process of using a new compound. The court relied on evidence showing that the nonaddictive property of the new compound was unexpected.). See also In re Tomlinson, 363 F.2d 928, 150 USPQ 623. "While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition." 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)).
Applicant argues that Kido’s broad disclosure in their claim 37 of “neurodegenerative disease is selected from the group consisting of Alzheimer's disease, senile dementia of Alzheimer type (SDAT), Parkinson's disease, Huntington's disease, Amyotrophic Lateral Sclerosis (ALS), ischemia, blindness and a neurodegenerative disease caused by injury to myelinated neurons.”, does not account for therapeutic treatments for AD. This is not found persuasive because this is a clear indication that one of ordinary skill in the art has contemplated using these cells as a therapeutic agent in AD treatments. Further, It would have been prima facie obvious to one of ordinary skill in the art to choose from the list of neurodegenerative diseases taught by Kido; such would amount to choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; which is proper to support a finding of obviousness under 35 U.S.C. 103(a). See the Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396). See also MPEP §2143(E).
An "obvious to try" rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. " [A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 35 U.S.C. 103." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). The teachings of Kido and Kim demonstrate that the ordinary artisan was aware of the criteria to determine what neurodegenerative diseases the disclosed method of treating would likely produce a positive treatment result. Thus, it would be conventional and within the skill of one in the art to identify the potential neurodegenerative disease that would benefit from this type of treatment.
Applicant’s dismissal of Kim as only teaching using PSA-NCAM positive cells to treat a neurodegenerative disease but not AD ignores the fact that the art already recognizes that these PSA-NCAM positive cells have already been shown capable to treat neuronal cell loss in another form of neuronal injury induced by neurodegeneration. Kido’s teachings provide clear motivation to one of ordinary skill in the art to have a reasonable expectation of success in using the PSA-NCAM positive cells to treat a neuronal injury caused by AD along with Kim’s disclosure using these PSA-NCAM positive NPCs as reliable cell source for future cell replacement therapy as cell therapy for neurodegenerative disorders. Kido provides working example of their cells, the same cells as the instantly claimed cells, that teaches that the PSA-NCAM positive NPCs are able to integrate into the adult mammalian brain, have full capacity of neural differentiation potential in vivo and have a significantly lower possibility of neural outgrowth when compared to unsorted and non-propagated neural rosette cells (see page 8, bottom of 2nd column). Kim teaches using these PSA-NCAM positive NPCs as reliable cell source for future cell replacement therapy as cell therapy for neurodegenerative disorders. Kim’s teaching provide clear evidence that this method of administering these cells are capable of being integrated in the CNS with neural degeneration and contradicts applicant’s argument that there is no working examples to support reasonable expectation of success. It is pointed out to Applicant that 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. “Good science and useful contributions do not necessarily result in patentability.” PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007). Therefore, the combination of the references of Kido and Kim provides a clear teaching that one of ordinary skill in the art would be motivated to use to use PSA-NCAM positive cells versus unsorted cells, as taught by Kim to produce the best result in treating injuries of the CNS like AD taught by Kido.
Applicant’s argument that there is no reasonable expectation of success is not found persuasive in view of the references of record. see MPEP § 2164.03 which states:
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification.”
The Kido and Kim references provide clear guidance to one of ordinary skill on how to produce the specifically claimed cells and provide a reasonable expectation of success in using these specific cells in AD subjects and have a reasonable expectation of success as set forth above.
Therefore, the applicant’s arguments are not found persuasive.
Conclusion
No claims allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Advisory Information
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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