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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 6, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 13 is objected to because of the following informalities:
both “vitamin” and “Vitamin” are recited. For consistency, appropriate correction is required.
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 1 – 15 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.
Claims 1 and its dependents are drawn to a “combination” however are rendered indefinite because it is unclear the “combination” encompasses a single composition requiring both vitamin C and Lactobacillus rhamnosus to be included therein or if the claim encompasses two separate compositions as in a kit. Clarification is required.
In claims 5, 12 – 15, the recitation of “more preferably,” “preferably,” and “including” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 8 and 10 are indefinite for reciting “a patient that is in need” as the phrase has not been adequately defined by the claim language or specification. For purposes of examination, the phrase is interpreted to be any patient.
Claims 9 and 15 recite the phrase “is suffering from” and “is experiencing”, respectively. The phrases are confusing because it is unclear what is required to meet the phrases as they appear to be subjective phrases intended to convey degrees of a condition without setting forth clear boundaries for what is required.
In claim 14, line 1, the recitation of “itamin” renders the claim indefinite as it is unclear what the word intends to encompass.
Claim 14 is indefinite because it is unclear how one can administer vitamin C and Lactobacillus rhamnosus at the same time and also sequentially. Clarification is required.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3 – 15 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Chen et al. (8697126 AND US 2009/0214647, cited by 2009/0214647).
Regarding claims 1, 3 and 5 Chen teaches a composition comprising vitamin C and Lactobacillus rhamnosus, wherein the compositions is oral form (abstract, 0009,0015, 0018, claims 18, 22, 24, 28, 32, 33).
Regarding claims 4 and 6 – 15, each of the claims recite an intended use of the composition. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Notwithstanding, Chen teaches the compositions include an enteral coating (0019, examples e.g., alginate) which is intended for enteral administration, or to the intestine, and is a delayed release coating.
Regarding claims 8, 10, 12, since the prior art teaches administering the same composition as claimed, the claimed functions must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Thus, the reference anticipates the claimed subject matter.
Claims 1, 3 – 15 are rejected under 35 U.S.C. 102a1 as being anticipated by Montorsi et al. (2016).
Regarding claims 1, 3 – 5 and 7 Montorsi teaches a combination of vitamin C and Lactobacillus rhamnosus, wherein the compositions are in oral form and administered together and/or sequentially as separate supplements (abstract, p.913).
Regarding claims 3 – 4 and 6 – 15, each of the claims recite an intended use of the composition. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claims 8, 10, 12, since the prior art teaches administering the same composition as claimed, the claimed functions must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Thus, the reference anticipates the claimed subject matter.
Claims 1 – 15 are rejected under 35 U.S.C. 102a1 as being anticipated by Culturelle® Kids Daily Immune Defense (2020).
Regarding claims 1 – 5 and 7 Culturelle® teaches a composition of vitamin C and Lactobacillus rhamnosus GG, wherein the composition is in oral form as a dietary supplement (p.1).
Regarding claims 3 – 4 and 6 – 15, each of the claims recite an intended use of the composition. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claims 8, 10, 12, since the prior art teaches administering the same composition as claimed, the claimed functions must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Thus, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
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.
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.
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 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (8697126 AND US 2009/0214647, cited by 2009/0214647) OR Montorsi et al. (2016); in view of Segers et al. (2014).
Regarding claim 1, Chen teaches a composition comprising vitamin C and Lactobacillus rhamnosus (abstract, 0009,0015, 0018, claims 18, 22, 24, 28, 32, 33); while Montorsi teaches a combination of vitamin C and Lactobacillus rhamnosus (abstract, p.913).
The references do not teach the composition or combination wherein the L. rhamnosus is L. rhamnosus GG. However, at the time the claims were filed, the claimed strain was well known and used in the art. In support, Segers teaches the strain is one of the most widely used and studied strains of L. rhamnosus and is known to prevent and treat gastrointestinal infections, diarrhea, stimulate immune response and prevent allergic reaction (abstract). At the time the claims were filed, one of ordinary skill in the art would have been motivated to use the claimed strain in the compositions and combinations of Chen and Montorsi as a matter of routine practice since the strain was well known and used, particularly for its therapeutic effects as evidenced by Segers, and with a reasonable expectation for successfully obtaining a composition/combination of vitamin C and L. rhamnosus.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
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 1 – 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 20, 24, 25 and 26 of U.S. Patent No.8697126. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued patent has claims to the same composition (claim 20, 26) as applicant.
Regarding instant claims 3 – 4 and 6 – 15, each of the claims recite an intended use of the composition. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding instant claims 8, 10, 12, since the prior art teaches administering the same composition as claimed, the claimed functions must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Claims 1 – 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 14 of copending Application No. 18/871 658 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim sets are drawn to the same combination of vitamin C and Lactobacillus rhamnosus GG (claims 1-2); same intended uses (claims 3 – 4, 6, 9, 11 - 13); same oral forms (claims 5, 7); same intended functions (claims 8, 10, 14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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