DETAILED ACTION
Applicants’ arguments, filed 6 August 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
An information disclosure statement (IDS) was submitted on 6 August 2026. This IDS cites multiple non-patent literature references. However, copies of the cited non-patent literature references do not appear to have been provided to the file record. As such, the IDS has not been considered. See MPEP 609.04(a)(II), which indicates that copies of non-patent literature references must be included with the IDS.
Claim Rejections - 35 USC § 112(a) – New Matter
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 1-5 and 18-21 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 18 have been amended to require that the exosomes comprise adipsin at a level at least about three times greater than in exosomes derived from a comparable population of Wnt- adipocytes of the same tissue origin. This newly added limitation appears to lack adequate support in the original application as filed and consequently appears to be drawn to new matter. The examiner presents the following in support of this position.
The instant specification discloses the following, as of page 11, top paragraph, relevant text reproduced below.
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As such, applicant has disclosed an example drawn to Wnt+ adipocytes which comprise adipsin at a level that is about 3.7 times higher than Wnt- adipocytes. This is insufficient to adequately support the claimed range of exosomes comprise adipsin at a level at least about three times greater than in exosomes derived from a comparable population of Wnt- adipocytes of the same tissue origin.
In support of this position, the examiner notes MPEP 2163.05(III), in which a case is cited showing that specific examples in the specification of the cited case of 36% and 60% failed to support a newly added claim limitation of at least 35%, because the newly added claim limitation of at least 35% had no upper limit. Similarly, the newly added claim limitation of adipisin at least about three times greater has no upper limit.
Additionally, a subgenus range may not be supported by generic disclosure and specific example within the subgenus range. See MPEP 2163(I)(B), first paragraph in section. In this case, the generic disclosure of adipocytes is disclosed in the specification, as is a specific example having 3.7 times the natural adipsin. However, this does not provide adequate support for a newly added limitation drawn to the subgenus of adipsin at a level at least about three times greater than in Wnt- exosomes.
As such, in view of these issues, the instant claims appear to be drawn to new matter and therefore appear to lack adequate support in the manner required by 35 U.S.C. 112(a).
Patent-Eligibility Rejection is Withdrawn
The instant claims were previously rejected under 35 U.S.C. 101 as being patent ineligible for being drawn to the judicial exception of a nature-based product. This rejection has been withdrawn. The examiner presents the following rationale for withdrawing this rejection.
When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A, as per MPEP 2106.04(b)(II), third paragraph in section. In this case, it is the examiner’s position that the claimed invention has markedly different characteristics as compared with natural adipocytes, and as such, the examiner has decided to withdraw the previously applied rejection for lack of patent eligibility. Applicant has presented arguments in support of this as of applicant’s response on 6 August 2026, page 7, second paragraph, relevant text reproduced below.
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The examiner agrees that the ability to treat diabetes mellitus, which would not have been found in natural adipocyte exosomes, is a markedly different characteristic. See MPEP 2106.04(c)(II)(B), especially example (v) in the section drawn to biological and/or pharmacological functions, which indicates that an ability to treat a disease not present in the natural product is a markedly different characteristic.
The examiner notes that adipsin itself is a natural product which has anti-diabetic effects. See applicant’s response, page 7, second to last paragraph, relevant text reproduced below.
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Nevertheless, the analysis drawn to markedly different characteristics applies to the composition as a whole, not to individual components, and a combination of adipsin at levels significantly higher than their natural levels with Wnt+ exosomes is not a naturally occurring product because these components are not found together in nature. The skilled artisan would have also expected that the claimed invention would have had more anti-diabetic effects than adipsin by itself in the absence of the exosome. This is because (a) exosomes are drug delivery vehicles which would have aided delivery of the adipsin and (b) the exosomes may have included other active components that would have worked in tandem with the adipsin in its physiological or pharmacological effect.
Relevant Prior Art – No Rejection
As relevant prior art over which the claims have not been rejected, the examiner cites Zhou et al. (Theranostics, Vol. 10 Issue 18, 2020, pages 8197-8210). Zhou et al. (hereafter referred to as Zhou) is drawn to exosomes derived from brown adipose tissue, as of Zhou, page 8197, title and abstract.
Zhou differs from the claimed invention because Zhou is silent as to whether the taught exosomes are from Wnt+ adipocytes. With that being said, the instant specification discloses the following, as of pages 11-12, paragraph 0023, reproduced below.
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As such, the skilled artisan would have expected that in the composition of Zhou, only a maximum of about 20% of the adipocytes would have been Wnt+ adipocytes. The examiner must provide rationale or evidence to show inherency, as per MPEP 2112(IV); in this case, the evidence provided by the specification would appear to go against the idea that the required amount of Wnt+ adipocytes would have been inherent in the composition of Zhou.
Additionally, there would have been no motivation for the skilled artisan to have increased the proportion of exosomes in Zhou that are Wnt+ exosomes because this concept is not taught by Zhou. This is at least because the issue of whether exosomes are Wnt+ has not been identified as a result-effective variable by Zhou, nor would there have been a design need or market pressure to solve the problem of Wnt+ concentration in the exosome population of Zhou by increasing the Wnt+ concentration. See MPEP 2144.05(II)(B), second paragraph in section, and MPEP 2144.05(III)(C). Additionally, even if, purely en arguendo, there were motivation for increasing the Wnt+ concentration in the exosome population of Zhou, it is unclear that there would have been a reasonable expectation that this could have been successfully achieved. See MPEP 2144.05(II)(B), first paragraph in section.
The examiner further notes that according to MPEP 2144.05(II)(A), generally, differences in concentration between the claimed invention and the prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. In support of this position, MPEP 2144.05(II)(A) cites In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the cited case, a claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.
With that being said, it is the examiner’s position that the instant claims, drawn to Wnt concentration on adipocyte membranes, differs substantially from the cited case. In the cited case, the relevant issue is the acid concentration, and the skilled artisan would have been able to have optimized the acid concentration by adding more acid or less acid. In contrast, in the instant case, Wnt is not added as a reagent (like the acid in the cited case), but is present in cells. As such, to increase or decrease the concentration of Wnt, the skilled artisan would need to separate cells comprising Wnt from those not comprising Wnt. There would have been no motivation for the skilled artisan to have done this, nor would there have been a reasonable expectation that this could have been done successfully. As such, the issue of optimizing the Wnt concentration in the instantly claimed invention and in the Zhou reference difers substantially from the issue of optimizing acid concentration of reagents such as acid in the cases cited in MPEP 2144.05(II)(A).
The examiner further clarifies that the presence of Wnt+ in a cell would have been expected to have resulted in a structural difference in the membrane of said cell as compared with a non-Wnt+ cell. The structural difference would appear to be the presence of palmitoylated Wnt proteins in the Wnt+ cell that would not have been present in the non-Wnt+ cell. This is described by Zhai et al. (The Journal of Biological Chemistry, Vol. 279 No. 32, August 2004, pages 33220-33227), as of at least the title and abstract of this reference. These palmitoylated proteins are present at the plasma membrane, as of Zhai, page 33220, right column, first full paragraph. As exosomes are obtained from retaining the cell membrane but removing the internal contents of the cell, the skilled artisan would have expected that the exosomes derived from Wnt+ adipocytes would have comprised palmitoylated Wnt proteins that would not have been present in the non-Wnt+ adipocytes. Therefore, the skilled artisan would have expected that there would have been a structural difference between the Wnt+ adipocyte exosomes and the non-Wnt+ adipocyte exosomes.
Conclusion
No claim is allowed.
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 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 ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
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