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.
Claim Status
Applicant’s arguments and amendments dated 2/5/26 have been received and entered in the application.
Claims 1-5, 7-15 are currently pending and examined on the merits.
Claims 1-2, 5, 7-11, 15 are currently amended.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
Claim Rejections - 35 USC § 112(a)/1st paragraph
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
Claims 1-5, 7-15 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
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-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish if). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G. D. Searie & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). See MPEP § 2163.
Claim 1 is directed to a method of “promoting brain plasticity… wherein the neurological disease is… a chronic phase of spinal cord injury”. Example 5 of the specification evaluates the effects of MSC administration on improved function in the spinal cord. The specification indicates that, with respect to spinal cord injury, improvement is due to remyelination at the site of injury (i.e., the spinal cord). Nothing in the specification as originally filed describes treating a spinal cord injury by improving brain function. Therefore, it is not clear that at the time of invention the applicants had full possession of the claims as presented.
Enablement
Claims 1-5, 7-15 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 enablement requirement. The specification contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” See MPEP § 2164. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill:
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples;
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
(A) With respect to the breadth of the claims, the claims as currently drafted encompass treating spinal cord injuries by administering MSCs. The claims are limited in that they require the injury to be treated by improving brain plasticity.
(B) The invention is in the field of spinal cord injury treatment.
(C)-(E) With respect to the state of the prior art, and predictability of the art, the prior art is silent as to treating spinal cord injury by improving brain plasticity with MSCs. Therefore, treating spinal cord injury by improving brain plasticity is an art with a very limited degree of unpredictability.
(F)-(G) The applicants have provided working examples directed to treating spinal cord injury by promoting remyelination at the site of a spinal cord injury. The applicants have not provided working examples for treating a spinal cord injury by improving brain plasticity.
(H) Undue experimentation would be required to practice the invention as claimed due to the amount of experimentation necessary because of the state of the prior art and its lack of predictability, and the lack of guidance in the form of varied working examples in the specification.
MPEP §2164.01(a), 4th paragraph, provides that, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC), states that, “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable,” citing Brenner v. Manson, 383 U.S. 519, 536 (1966) (stating, in the context of the utility requirement, that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion”). The Genentech decision continued, “tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Id. at p. 1005.
After applying the Wands factors and analysis to claims 1-5, 7-15, in view of the applicant’s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in claims 1-5, 15 would not be enabled by the written disclosure. Therefore, claims 1-5, 7-15 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to use the invention.
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.
Claims 1-5, 7-15 are rejected under 35 U.S.C. 103 as being unpatentable over Honmo et al., JP2012100662 (cited on IDS dated 10/26/18, hereinafter Honmo) in view of Dobkin, B.H., (2013) New evidence for therapies in stroke rehabilitation. Current Atherosclerosis Reports. 15(331) https://doi.org/10.1007/s11883-013-0331-y (hereinafter Dobkin).
Regarding claims 1, 8-9, 11-13, Honmo discloses methods of collecting and culturing cells for promoting repair and regeneration of tissues (Abstract). Honmo discloses collecting bone marrow fluid from a patient suffering from a brain disease (para 51, 139). The fluid is collected into a tube containing 0.1U heparin/mL of bone marrow fluid, combined with culture media containing peripheral blood-derived serum, and cultured (para 97, 139-140). Honmo explains that addition of heparin in the culture media exerts and inhibitory effect on proliferation, and should therefore be limited (para 52-54, 144). The cells to be cultured may be any adherent cell type prepared from a sample containing blood components, preferably MSCs (para 59-61, 80). The resultant MSCs do not demonstrate expression of CD24 (para 29, 73, 172, Table 1). The MSCs may be used to treat a variety of neurological conditions, including dementia, spinal cord injury, mental illness, and cerebral infarction (para 39, 85, 91, 124). The cells may be administered via intravenous administration, lumber puncture, intracerebral administration, intraventricular administration, local administration, or intraarterial administration (para 33, 44, 98, 174). Subjects receiving the MSCs demonstrate improved motor function, decreased cerebral infarctions, improved cerebral blood flow, improved muscular strength, improvement in spinal cord injury recovery, etc. (para 175-191, Fig. 10-23). The MSCs aid repair of the injured site through means including nerve regeneration (para 34). Honmo explains that the MSCs aid repair of damaged tissue by restoring and regenerating function of the damaged tissue (para 34, 85, 126). Restoration and regeneration with respect to brain tissue may be accomplished via nerve regeneration, protective action of neurons, such as through remyelination, neurotrophic action, cerebrovascularization, etc. (para 34, 126).
Regarding claim 2, Honmo discloses that he resultant MSCs demonstrate positive expression of CD73, CD105, and CD200, and negative expression of CD19, CD34, CD45, CD74, and CD79 (para 73, 143, Table 1).
Regarding claims 3-5, 7, 14-15 are directed to limitations which express an intended result of the method, and do not recite any active method steps. As per MPEP § 2111.04, limitations which merely express an intended result of a method are not given patentable weight.
Regarding claim 10, the serum may be either allogeneic or autologous serum (para 58).
Honmo does not disclose that the MSCs may be used to promote brain plasticity, nor does Honmo disclose that the MSCs may be used to promote synapse formation. However, Honmo discloses that the MSCs promote nerve regeneration and neurotrophic action, among other regenerative actions (para 34, 85, 126). As new neurons may be formed, there is a suggestion present in Honmo that synaptogenesis is likewise occurring, and concomitant improvements in brain plasticity. This conclusion is supported by data indicating that subjects undergoing treatment demonstrated significant improvements following cerebral infarctions (para 175-191, Fig. 10-23). Therefore, there is a suggestion present in Honmo that the disclosed MSCs could be utilized to promote synapse formation and/or brain plasticity.
Honmo does not disclose that MSC administration is combined with physical rehabilitation.
Dobkin reviews therapies in stroke rehabilitation (Abstract). Dobkin explains that physical activity and rehabilitation are well-known modalities for post-stroke therapy (Principles underlying rehabilitative therapies, Fitness and muscle strength). Dobkin discloses that physical rehabilitation is associated with greater neurogenesis and improvement on cognitive tasks (Fitness and muscle strength). Dobkin also explains that mesenchymal stem therapy trials are ongoing for treatment of stroke (Cell-based and biologic therapies). Dobkin suggests that any cell-based or biologic interventions need to be combined with other rehabilitation therapies to optimize their effects (Cell-based and biologic therapies). As both Honmo and Dobkin are directed to therapies for cerebral infarction, including cell-based therapies, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to combine the references to improve the therapeutic outcome as suggested by Dobkin.
Response to Arguments
Applicant’s arguments and affidavit dated 2/5/26 have been fully considered but are not persuasive as explained in detail below.
Claims 1-5, 7-15 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.
Applicant argues that the specification as originally filed describes treating a spinal cord injury by improving brain function as demonstrated by Example 5 and Figures 21-23 (Response p6-9, Affidavit p3-4).
The present claims do not require that the MSCs function at a site of damage. Under a broadest reasonable interpretation, the claims as presented encompass treating a spinal cord injury by promoting brain plasticity alone without requiring any regeneration or functional restoration of neurons in the spinal cord. Both applicant’s response and affidavit demonstrate that treatment of a spinal cord injury requires regeneration and functional restoration of neurons in the spinal cord. Therefore, the specification does not provide written description for the full scope of the invention as claimed.
Claims 1-5, 7-15 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 enablement requirement.
Applicant argues that the specification at Example 5 demonstrates a working example for treating a spinal cord injury by improving brain plasticity (Response p10-11, Affidavit p4-5).
As discussed supra under a broadest reasonable interpretation, the claims as presented encompass treating a spinal cord injury by promoting brain plasticity alone without requiring any regeneration or functional restoration of neurons in the spinal cord. Example 5 demonstrates treatment of a spinal cord injury requires regeneration and functional restoration of neurons in the spinal cord. Nothing in the specification or applicant’s affidavit provides guidance as to how a spinal cord injury could be successfully treated without treatment at the site of injury. Therefore, it is not clear that applicants disclosed sufficient information to enable a person of skill in the art to use the full scope of invention.
Claims 1-5, 7-15 are rejected under 35 U.S.C. 103 as being unpatentable over Honmo in view of Dobkin.
Applicant argues that Honmou fails to disclose or suggest promoting brain plasticity (Response p11). Applicant argues that nerve regeneration and brain plasticity are distinct biological phenomena; that brain plasticity comprises compensation of functional reorganization of neurons (Response p11).
In response, neuroplasticity is art understood to encompass both neuronal regeneration and functional reorganization. See for example, Puderbaugh M, Emmady PD. Neuroplasticity. [Updated 2023 May 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557811/ (hereinafter Puderbagh) which describes neuroplasticity as “the ability of the nervous system to change its activity in response to intrinsic or extrinsic stimuli by reorganizing its structure, functions, or connections” including both neuronal regeneration and functional reorganization. Therefore, applicant’s claims are not so limited as applicant is arguing, and the neuronal regeneration of Honmou is deemed to obviate the claims as presented.
Applicant argues that Honmou fails to disclose or suggest compensatory reorganization in undamaged brain regions (Response p11-12).
As noted in the art rejections, the limitations directed to compensatory reorganization are written such that they merely express an intended result of the method, and do not recite any active method steps. As per MPEP § 2111.04, limitations which merely express an intended result of a method are not given patentable weight. As the combination is deemed to obviate the actively recited method steps, the intended results are considered to be obviated.
Applicant argues that Dobkin fails to cure the deficiencies noted in Honmou (Response p12).
As discussed supra, the examiner disagrees that Honmou in combination with Dobkin fails to obviate the claims as presented.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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