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 .
Claims 1-7 and 9-20 are presented for examination.
Applicants’ amendments, information disclosure statement, response, and terminal disclaimer filed December 29, 2025 have been received and entered.
Substituted specification filed December 29, 2025 has been entered.
Accordingly, the rejection made under provisional non-statutory double patenting as being unpatentable over claims 1-8 of copending Application No. 17/782,140 (reference application) as set forth in the previous Office action dated September 25, 2025 at pages 3-5 as applied to claims 1-11 and 20 is hereby WITHDRAWN because the applicants filed a terminal disclaimer.
Accordingly, the rejection made under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph as being indefinite for failing to particularly point out and distinctly claim the subject matter as set forth in the previous Office action dated September 25, 2025 at pages 5-6 as applied to claims 10-11 is hereby WITHDRAWN due to applicants’ amendment to claim 10.
Accordingly, the rejection made under 35 USC 103 as being unpatentable over CN 101804196 A, hereby known as Bu as set forth in the previous Office action dated September 25, 2025 at pages 6-8 as applied to claims 1-6, 8 and 9 is hereby WITHDRAWN because the prior art does not teach applicants’ preferred ratios of sucrester to phospholipid in the instant nutritional powder formulation.
Claims 12-19 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
Applicants request the rejoinder of non-elected claims 12-19.
The request for rejoinder is APPROVED and claims 12-19 will be examined.
Allowable Subject Matter
Claims 1-7, 9-11, 17-20 are allowable.
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.
Claim 14 is 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.
This is a Written Description rejection.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases of any of the agents demonstrating wherein possession of use of the broad term: carbohydrate metabolism, symptom or disorder related thereto. The mere fact that Applicant may have discovered one type of carbohydrate metabolism, symptom or disorder related thereto with administering of an effective amount of the solid form formulation is not sufficient to claim the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Claim 14 is not allowed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 is rendered indefinite and vague by the phrase “A method to treat a subject”. What is the subject being treated for ? A condition, disease, or disorder. This phrase is confusing.
Claims 13 and 14, the applicants may to insert the phrase –thereof--, after the phrase “in need” to have many clarity in the claims for preventive and/or curative treatment.
Regarding claim 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 16 is rendered indefinite to the extent that it incorporates the above terminology.
Claims 12-16 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629
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