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 .
Application Status
Claim 1-24 are under examination.
Claim 1-24 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/31/2024 and 11/05/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 12 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 11. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim 1-27 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 1 recites the limitation "the normal caloric intake" in line 4. There is insufficient antecedent basis for this limitation in the claim.
The term “less than about 50% of the normal caloric intake of the subject” in claim 1is a relative term which renders the claim indefinite. The term “normal caloric intake” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear as what range or value of calories does Applicant intend to encompass as “normal caloric intake” to meet the limitation of “less than about 50%”. It was well known in the art in particular with respect to human being as a subject, wherein gender, age, body size, body mass, and activity level all play a part with respect to normal caloric intake differs; hence it is not clear as to what the term “normal” encompass to meet the claim limitation. Claim 2-20 are also rejected since the claims are depended upon rejected claim 1.
Claim 8 recites the limitation "the first day" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the second to fifth days" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the first day" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the second to fifth days" in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the second to fifth days" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The term “per day for days 1-5” in claim 14, 15 and 16 are confusing since the independent claim 1 does not recite day or days. The claims are indefinite.
Claim 17 recites the limitation "the entire 5-day period" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the first day" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the second day to the fifth day" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the micronutrients" in line 21. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the sequencing of ration consumption" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The term “normal diet during refeeding periods” in claim 23 is a relative term which renders the claim indefinite. The term “normal diet” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It was well known in the art in particular with respect to human being as a subject, wherein gender, age, body size, body mass, and activity level all play a part with respect to normal caloric intake differs; hence it is not clear as to what the term “normal” encompass to meet the claim limitation.
Claim 24 recites the limitation "the diet period" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reda (WO 2008/042263 A1).
Regarding claim 1, Reda discloses a packaged food delivery system (diet package) comprising nutritional bars (rations) (pg. 2, ln. 5-10) wherein the nutritional bars (rations) includes plurality of nutrition bars with amounts of calories, carbohydrates, protein and fats (pg. 3, ln. 8-15). Reda teaches the nutritional bars (rations) to be administered in different time intervals (time periods) wherein first food bar (ration) as first meal (pg. 5, ln. 1-13) for specified diet plan for weight reduction (pg. 4, ln. 1-5).
Reda teaches the specified diet plan for the weight reduction a 40 year female (subject) at 110 lbs with a maintained (normal) caloric intake of 1977 daily caloric intake to a daily caloric intake of 977 (pg. 19, Table T9), which is about 50% less than the maintained (normal) caloric intake, and within the claimed range. With respect to the limitation of “both protein restriction and sugar restriction”, Reda encompass the limitation since Reda clearly teaches a reduced caloric intake to in the specified diet plan for the weight reduction, which encompasses a protein restriction and sugar restriction (pg. 5, ln. 18-23).
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.
Claim 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 11,992,036. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1-27 recites same diet package for administering a fasting mimicking diet comprising rations with overlapping time periods, days, caloric intakes and components such as proteins, sugars, saturated fats, glycerol, vitamins as in 1-20 of U.S. Patent No. 11,992,036.
Claim 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 of U.S. Patent No. 10,932,486. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1-27 recites same diet package for administering a fasting mimicking diet comprising rations with overlapping time periods, days, caloric intakes and components such as proteins, sugars, saturated fats, glycerol, vitamin C and D, as in 1-6 of U.S. Patent No. 10,932,486.
Claim 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 of U.S. Patent No. 10,433,576. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1-27 recites same diet package for administering a fasting mimicking diet comprising rations with overlapping time periods, days, caloric intakes and components such as proteins, sugars, saturated fats, glycerol, vitamin C and D, as in claim 1-11 of U.S. Patent No. 10,433,576.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
No art-based rejection over claim 2-27, is being provided because other available prior art does not teach or suggest singularly or in combination at least the limitations in of claim 2-27. The closest prior art, Reda discloses a packaged food delivery system (diet package) comprising nutritional bars (rations) (pg. 2, ln. 5-10) wherein the nutritional bars (rations) includes plurality of nutrition bars with amounts of calories, carbohydrates, protein and fats (pg. 3, ln. 8-15). Reda teaches the nutritional bars (rations) to be administered in different time intervals (time periods) wherein first food bar (ration) as first meal (pg. 5, ln. 1-13) for specified diet plan for weight reduction (pg. 4, ln. 1-5). However, the prior art, Reda does not singularly teach or suggest a motivation for a combination under obviousness, as recited in claim 2-27.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG THI YOO whose telephone number is (571)270-7093. The examiner can normally be reached M-F, 7AM to 3PM.
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/HONG T YOO/Primary Examiner, Art Unit 1792