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 of species modulating an immune response, inhibition of interferon-γ, disease associated damage, autoimmune disease, and hypoxia in the reply filed on 11/28/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 21-40 are currently pending.
Claims 1-20 have been canceled in a preliminary amendment on 02/09/2024.
Claims 24-25, 28, 39-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/28/2025.
Claims 21-23, 26-27, 29-38 have been examined on their merits.
Claim Objections
Claim 21 is objected to because of the following informalities:
Claim 21 is a new claim, but also has a strikethrough markup in step (c) through the word “the”. New claims should not have any markups.
In addition, the current claim listing presented does not include claims 1-20 which have the status of “canceled”. All future claims listing must include claims 1-20 with the status of “canceled” along with claims 21-40 with the status of “previously presented”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 21-23, 27, 29-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating tissue damage associated with an autoimmune disease in a subject, does not reasonably provide enablement for modulating any and all immune responses in any and all subjects.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir.1988). The court in Wands states: “Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue,’ not ‘experimentation.’ ”(Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the predictability or unpredictability of the art, (5) the relative skill of those in the art, (6) the amount or direction or guidance presented, (7) the presence or absence of working examples, and (8) the quantity of experimentation necessary.
N.B. MPEP 2164.04 states, “[w]hile the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection” and that “[t]he language should focus on those factors, reasons, and evidence that lead the examiner to conclude that the specification fails to teach how to make and use the claimed invention without undue experimentation, or that the scope of any enablement provided to one skilled in the art is not commensurate with the scope of protection sought by the claims.” Accordingly, the Factors most relevant to the instant rejection are addressed in detail below.
1-2 .Breadth of the claims and the nature of the invention..
In regards to the method of the invention and the breadth of the claims the broadest interpretation that applies is a method that modulates an immune response in any type of subject by administering a composition comprising PASCs that have been prepared by a specific method and administering them under conditions permitting the PASCs to divide and populate a site of tissue damage. The claims are broad in that they encompass any type of modulation of an immune system in any subject.
3-4. The state of prior art and the level of predictability in the art.
The prior art indicates that the use of adipose-derived stem cells for administration to a subject includes several issues that are yet to be fully addressed including the lack of standardization of ADSC-associated protocols, the methods used to obtain them, inconsistent dosages, small numbers of patients in each treatment groups and variable graft purity. This leads to the dilemma of inconsistent results attributable to poor standardization as disclosed by Skrypnyk et al (Journal of Umm Al-Qura University for Applied Sciences, (2025), abstract and page 69).
Qin et al disclose that another challenge in the clinical translation of ADSC-based therapies is the uncertainty regarding their clinical efficacy. Most of our understanding of ADSCs today comes from studies performed on in vitro 2D cell culture systems, which generally ignore critical characteristics such as cell–cell and cell–extracellular cell matrix (ECM) interactions, tissue architecture, and biophysical cues of the 3D niche. Although animal models have been employed in preclinical studies to evaluate the efficacy and safety of therapies, researchers have found it difficult to apply their success in clinical settings because of the lack of physiological, molecular, and genetic relevance to human clinical conditions. Worse still, the absence of standard procedures for applying ADSCs leads to varied cell qualities, which increases the uncertainty of their clinical efficacy. The intrinsic characteristics of donors can influence the properties of isolated ADSCs (Advanced Science, 2023, page 4).
Larocca et al disclose that interferon-γ expression was higher in the draining lymph nodes of an ADSC treated group but lower in the graft of the untreated group (PLoS ONE, 2013, pages 6-7).
5. The relative skill in the art.
The relative skill in the art as it relates to the method of the invention is characterized by that of a M.D. or Ph. D. level individual.
6-7. The amount of guidance present and the existence of working examples.
Applicant does not provide any working examples in the instant specification that represents the full scope of the claimed method of administering their claimed PASCs to a subject and modulating the immune response of the subject. While in vitro cultures of splenocytes and mice diabetic models are used to demonstrate the effect of the administered PASCs this falls short of modulating the immune response of any type of subject for any type of immune response.
8. The quantity of experimentation necessary.
The amount of experimentation that is required is undue:
A method of modulating any immune response for any type of subject requires the testing of various variables that would affect the outcome of the claimed method.
Although animal models have been employed in preclinical studies to evaluate the efficacy and safety of therapies, researchers have found it difficult to apply their success in clinical settings because of the lack of physiological, molecular, and genetic relevance to human clinical conditions. Worse still, the absence of standard procedures for applying ADSCs leads to varied cell qualities, which increases the uncertainty of their clinical efficacy. The intrinsic characteristics of donors can influence the properties of isolated ADSCs (Advanced Science, 2023, page 4).
Therefore, in view of the overly broad scope of the claims, the Iack of guidance and working examples provided in the specification, and the high degree of unpredictability as evidenced by the prior art, undue experimentation would be necessary for a skilled artisan to make and use the entire scope of the claimed invention.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under USC 112, first paragraph for the reasons set forth above.
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 21-23, 26-27, 29-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9-17 of U.S. Patent No. 11,913,027.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method of treating disease-associated damage, such as an autoimmune disease-associated damage, in a subject comprising administering PASCs that have been obtained and administered in the same manner as the currently claimed method. The effects of the administration for immunomodulation, such as the type of immune response, are deemed to be inherently present since the steps are the same.
Therefore, the teachings of the patent render anticipate the claims of the current
Claims 21-23, 26-27, 29-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 8-13 of U.S. Patent No. 11,066,647.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method of ameliorating tissue damage in a subject, such as disease-associated damage, such as an autoimmune disease-associated damage, in a subject comprising administering PASCs that have been obtained and administered in the same manner as the currently claimed method. The effects of the administration for immunomodulation, such as the type of immune response, are deemed to be inherently present since the steps are the same.
Therefore, the teachings of the patent render anticipate the claims of the current
Claims 21-23, 26-27, 29-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 8-13 of U.S. Patent No. 10,131,880 in view of Ra et al (Journal of Translational Medicine, 2011).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '880 patent are drawn to a method of isolating pluripotent stem cells from adipose tissue by method steps that include the same isolating steps as claimed in the current method, but are silent to how the recovered pluripotent adipose stem cells are used.
Ra teach that adipose stem cells can be used in cell therapy, specifically to treat autoimmune diseases by administering the cells to a subject with tissue damaged by an autoimmune disease (abstract, page 7 conclusion).
One of ordinary skill in the art would have been motivated to use the adipose for the treatment of tissue damage associated with an autoimmune disease with a reasonable expectation of success because Safford teach and suggest that adipose derived stem cells are suitable for use in the treatment of autoimmune disease tissue damage.
Therefore, the combined teachings of patent '880 and Ra et al render obvious Applicant's invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kang, Soo-Kyung, “Method For Dedifferentiating Adipose Tissue Stromal Cells”, US 20120003186 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631