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 .
Claims 1-15 are pending and have been considered on the merits herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The claims are drawn to a combination/product comprising vitamin B2 and Lactobacillus rhamnosus. Claims 3, 4, 6-15 contain intended use type limitations. A prior art reference which teaches the claimed structural composition is taken to be one which anticipates the intended use type claims. See MPEP 2112.01 I and II.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claim(s) recite(s) a product of nature without significantly more. The claims recite a combination of vitamin B2 and Lactobacillus rhamnosus GG, both products of nature. This judicial exception is not integrated into a practical application because the claims are directed to a product of nature with no practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the product of nature claims does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state. “If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim is directed to a ‘product of nature’ exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception and do they integrate the exception into a practical application. It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” MPEP 2106.04(b)(ll). “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis.
Here, the claims are directed towards a combination of vitamin B2 and Lactobacillus rhamnosus GG, both products of nature. There is nothing which indicates that the combination of natural products is markedly different from their naturally occurring counterparts and is directed to a product of nature.
Regarding Step 2B, the claims do not recite any additional elements. Thus, the claim is directed to a judicial exception. Next, one must evaluate whether the claims as a whole integrate the judicial exception into a practical application, thereby imposing a meaningful limit on the judicial exception. Thus, one must identify whether there are any additional elements recited in the claim beyond the judicial exception. In the instant claims, there is not a practical application beyond the judicial exception.
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 1-15 is/are determined to be directed to a judicial exception.
For these reasons the claims are rejected under section 101 as being directed tonon-statutory subject matter.
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 5, 12, 14, 15 is 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.
Regarding claim 5, the phrase "more preferably" and in claims 12, and 14 “preferably” render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Additionally, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “an oral dosage form”, and the claim also recites “more preferably a solid oral dosage form” which is the narrower statement of the range/limitation. Claims 12, 14, recite the broad recitation “an animal or the animal”, and the claim also recites “preferably a human” which is the narrower statement of the range/limitation and claim 15 recites the broad limitation “the animal”, followed by the narrower statement of “including a human”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim(s) 1, 3-15 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by EP2022502 (IDS).
Regarding claims 1, 3-15, EP502 teaches a combination of vitamin B2 (riboflavin) and Lactobacillus rhamnosus. The reference teaches a composition comprising vitamin B2 (0029) and Lactobacillus rhamnosus (0010, 0039, 0040, 0046-0054, for example).
Regarding claim 5, the combination is in oral dosage form including as a food product (0031, 0040).
Claims 3, 4, 6- 15 are drawn to the intended use of the claimed product. The intended use and function of the claimed product does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Any product having the same structure is capable of the claimed intended use. 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). Moreover, the claimed function 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).
The reference anticipates the claimed subject matter.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by KR20080016391A (IDS).
Regarding claims 1-15, KR391 teaches a combination of vitamin B2 (riboflavin) and Lactobacillus rhamnosus GG. The reference teaches a composition comprising vitamin B2 (Formulation 3, for example) and Lactobacillus rhamnosus GG (abstract, p. 2, description section 2nd para., p. 3, 3rd from last parag.,p. 5, 5th parag., p. 12, Formulation 3, for example).
Regarding claim 5, the combination is in oral dosage form including tablets, capsules, dietary supplement, or food product (p. 4, whole page).
Claims 3, 4, 6- 15 are drawn to the intended use of the claimed product. The intended use and function of the claimed product does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Any product having the same structure is capable of the claimed intended use. Please note that when applicant claims acomposition 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). Moreover, the claimed function 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).
The reference anticipates the claimed subject matter.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO2005/063200A2 to Henriksen.
Regarding claims 1-15, WO200 teaches a combination of vitamin B2 (riboflavin) and Lactobacillus rhamnosus GG. The reference teaches a composition comprising vitamin B2 (p. 1, lines 1-6, p. 3, lines 12-15, p. 4-5, List C, Ex. 1-3) and Lactobacillus rhamnosus GG (p. 1, lines 1-6, p. 3, lines 12-15, Ex. 1-3, for example).
Regarding claim 5, the combination is in oral dosage form including tablets, for example (p. 1, lines 1-6, Ex. 1-3, see entire document).
Claims 3, 4, 6- 15 are drawn to the intended use of the claimed product. The intended use and function of the claimed product does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Any product having the same structure is capable of the claimed intended use. Please note that when applicant claims acomposition 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). Moreover, the claimed function 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).
The reference anticipates the claimed subject matter.
Claim(s) 1, 3-15 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by CN107927794A (IDS).
Regarding claims 1, 3-15, CN794 teaches a combination of vitamin B2 (riboflavin) and Lactobacillus rhamnosus. The reference teaches a composition comprising vitamin B2 and Lactobacillus rhamnosus (abstract, claims 1-3, p. 3, last parag., p. 5, 1st parag., , 4th parag., 7th parag., for example).
Regarding claim 5, the combination is in oral dosage form including as a food product (p. 2, claims 4 and 5, p. 3, 6th parag., p. 4, 3rd and 4th parag.).
Claims 3, 4, 6- 15 are drawn to the intended use of the claimed product. The intended use and function of the claimed product does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Any product having the same structure is capable of the claimed intended use. Please note that when applicant claims acomposition 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). Moreover, the claimed function 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).
The reference anticipates the claimed subject matter.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
5 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 7 of copending Application No. 18872488 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1-7 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-7 of copending Application No. 18872700 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18872700 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to a combination comprising vitamin B2 and Lactobacillus rhamnosus particularly, L. rhamnosus GG. While claims 1-7 of the instant application and the reference application are identical, claims 8-15 differ in that the “combinations” have different claimed intended use type limitations; however, the combinations/products are the same and thus, must be capable of performing the claimed intended use.
The intended use and function of the claimed product does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Any product having the same structure is capable of the claimed intended use. Moreover, the claimed function 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18872488 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claimed inventions are directed to compositions comprising vitamin B2 and Lactobacillus rhamnosus.
Regarding instant claims 1-4, claim 1 of '488 recites a vitamin B2 composition. Claims 4 and 14 of '488 recite that vitamin B2 is co-administered with Lactobacillus rhamnosus GG. Co-administration as set forth in the specification of '488 includes simultaneous and sequential administration of the vitamin and probiotic. Claim 7 of '488 recites that the combination is an oral dosage form. Regarding instant claims 8-15, the limitations of these claims are intended use limitations. The claims of '488 recite the same composition as the instant claims, which must be capable of performing the intended use. Additionally, the intended use of instant claim 15 overlaps with the method of treating cancer, intestinal disorders, liver disease, for example of reference claim 13.
The intended use and function of the claimed product does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Any product having the same structure is capable of the claimed intended use. Moreover, the claimed function 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651
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