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 .
Claim Objections
Claim 1 is objected to because of the following informalities: the term “and” should be added between after β-1,3/1,6- glucan to show the composition comprises i) and ii). Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the term “and” should be added between after β-1,3/1,6- glucan to show the composition comprises i) and ii). Appropriate correction is required.
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 1-7, 9-16, and 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 1-7, 9-16, and 18-19 are directed to a natural phenomenon (i.e., a law of nature and a product of nature). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception - i.e., as drafted, the cited claims read upon a product of nature for the following reasons:
The present claims are drawn to a composition (as a food) comprising β-1,3/1,6- glucan and polyphenolic isoflavonoids. It is noted the β-1,3/1,6- glucan are taught to be obtained from yeast, bacteria, fungi and cereal grains (see [0030] herein) and the polyphenolic isoflavonoids are taught to be from various natural products such as soy isoflavones derived from soybeans (see [0036] herein). As such, the β-1,3/1,6- glucan and isoflavonoids both embrace naturally occurring products. Dependent claims provide the composition further comprises a prebiotic component comprising beet pulp, citrus pulp, or a mixture thereof; and also one or more germinated seeds; also naturally occurring products.
The claimed composition is not markedly different from its/their naturally-occurring counterpart(s) because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring counterpart(s) (including the natural compounds found therein). The cited claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements.
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart(s) (see, e.g., Diamond V. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural products does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. - 333 U.S. 127 (1948)) because again there is no evidence of a marked difference brought about by combining the instantly claimed natural products. Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology V. Myriad Genetics, Inc., 569 U.S. ___ , 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible 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.
Claim 7 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.
Claim 7 recites the limitation "wherein the prebiotic component" in the 2nd line. There is insufficient antecedent basis for this limitation in the claim as the claim, nor the claims from which it depends – claim 1, does not reference any “prebiotic component”. It is noted that changing this claim to depend on claim 5 or claim 13 would overcome this rejection.
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.
Claim(s) 1-5, 9-16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN109156602A (Foreign Patent No. 1 from applicant’s IDS filed 9/28/23).
‘602A discloses pet food compositions comprising 1.5-3 parts yeast cell walls and 0.8-1.2 parts soy isoflavones. Yeast cell walls are known to comprise β-1,3/1,6-glucan (see [0031] herein) and soy isoflavones are known to be polyphenolic (see Sahin et al. – Integrative Cancer Therapies, vol. 18, 2019, pp 1-11; stating genistein is the predominant isoflavone is soy – see paragraph 1 of introduction). As such, the compositions comprise the two required agents herein in the required amounts (see abstract and examples). Likewise, the compositions also comprise oat husk powder, which is known to be a prebiotic. Regarding the present limitations of the compositions after 3 days of post-ingestion by a pet, an increase in weight ratio of propionate to branched short chain fatty acids (BSCFA) in the feces are increased and ratio of SCFA to BSCFA in the feces is increased – these limitations would be met by the compositions of the art since they contain the same active agents, and thus would expect to produce the same results upon administration. The pet food of ‘602A, when administered would have inherently produced the results claimed in the compositions herein as they are directly related to composition in the art. It is noted that if ‘602A, having taken the manipulative steps described therein, had attempted to measure for the results as described in the instant application, they would have uncovered those results, as they are directly correlative to steps practiced therein with the same pet foods claimed herein. Applicant's discovery of differing effects of a prior art composition does not give the discoverer a right to exclude others from using the compositions of the prior art, as the prior arts compositions would have inherently produced the results as instantly claimed upon administration. See Ex Parte Novitski, 26 USPQ 2d (BNA) 1389. A hypothetical example clarifies this principle. Humans lit fires for thousands of years before realizing that oxygen is necessary to create and maintain a flame. The first person to discover the necessity of oxygen certainly could not have obtained a valid patent claim for "a method of making a fire by lighting a flame in the presence of oxygen." Even if prior art on lighting fires did not disclose the importance of oxygen and one of ordinary skill in the art did not know about the importance of oxygen, understanding this law of nature would not give the discoverer a right to exclude others from practicing the prior art of making fires. EMI v. Cypress Semiconductor, 2001 US Fed. Cir. Ct. of App. Another example would be, someone finding out that aspirin for example, cured psoriasis. One would not expect them to then obtain a patent for a composition comprising aspirin for curing psoriasis when the identical composition was used for years for other purposes. Additionally, since the Office does not have the facilities for preparing the claimed materials and comparing them with prior art inventions, the burden is on Applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6, 9-16, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,842,809.
The claims of the present application are drawn to pet food compositions comprising β-1,3/1,6-glucan and polyphenolic isoflavonoids having a ratio of about 1:1 to 5:1. Dependent claims provide for various ratios such as about 2:1; and to include additional prebiotic component such as beet pulp or citrus pulp or combinations thereof. Also claimed are limitations on the amount of the agents in the composition based on the total weight of the composition such as the β-glucan in an amount from 0.1-10 or 0.3-5wt% and the isoflavonoids are from about 0.01-1 or 0.05-0.5wt%. Applicants also provide limitations which would occur after administration of the composition – such as that after 3 days of administration an increase in a weight ratio of propionate to BSCFA and an increase in weight ratio of SCFA to BSCFA in the feces occurs. Also claimed are methods of alleviating, mitigating, and/or reducing renal disease comprising administering the compositions herein to a pet.
‘809 is drawn to pet food compositions comprising from 0.01-0.05 wt% soy isoflavone; 0.1-1 wt% β-glucan and various other ingredients (see Table 1). Table 2 shows beet pulp and citrus pulp in combination with soy isoflavone and yeast β-glucan. As set forth above – it is noted that soy isoflavone is known to comprise the polyphenolic isoflavonoids claimed herein and yeast β-glucan is known to contain the β-1,3/1,6-glucan claimed herein. ‘809 also states that the combination of soy isoflavone and β-glucan increased production of SCFA after both 6 and 24hours; and shifted the type of SCFA produced in the feces to favor propionate at the expense of other SCFA (see table 2 and column 8, lines 24-40). What is not taught is the exact ratio claimed herein, nor to treat renal diseases as claimed herein.
It would have been obvious to one of kill in the art to modify the compositions of ‘809 and arrive at the present compositions as the difference is minor in merely changing amounts of agents to be included therein wherein ‘809 teaches a ratio of about 23:1 to about 7:1 of β-glucan:isoflavone and the present application has a range of about 1:1 to 5:1 of β-glucan:isoflavone. This modification of amounts is well within the purview of a skilled artisan looking for new compositions. Modifying the amounts of the active agents is seen to be obvious absent a showing of unexpected results which are commensurate in scope with the claims. Likewise, ‘809 teaches that the addition of isoflavone to their β-glucan composition increases the production of propionate and SCFA in the feces of canines after administration. Moreover, it would be expected that if these were increased after 6 and 24 hours as taught by ‘809, they would also be increased comparatively after 3 days, since the same or substantially similar compositions are administered to the same population as done herein. Likewise, it would have been obvious to use the compositions for treating a renal disease as claimed herein as they are taught to be used for controlling post-prandial glucose levels and managing glucose levels in a pet. Thus treating renal diseases as claimed herein would have been obvious to a skilled artisan as renal diseases are known to beneficially treated by lowering blood glucose.
Claim(s) 1-7, 9-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,842,809 in view of WO2011/116480.
The claims of the present application are drawn to pet food compositions comprising β-1,3/1,6-glucan and polyphenolic isoflavonoids having a ratio of about 1:1 to 5:1. Dependent claims provide for various ratios such as about 2:1; and to include additional prebiotic component such as beet pulp or citrus pulp or combinations thereof, or germinated seeds. Also claimed are limitations on the amount of the agents in the composition based on the total weight of the composition. Applicants also provide limitations which would occur after administration of the composition – such as that after 3 days of administration an increase in a weight ratio of propionate to BSCFA and an increase in weight ratio of SCFA to BSCFA in the feces occurs.
‘809 is drawn to pet food compositions comprising from 0.01-0.05 wt% soy isoflavone; 0.1-1 wt% β-glucan and various other ingredients (see Table 1). Table 2 shows beet pulp and citrus pulp in combination with soy isoflavone and yeast β-glucan. Again – it is noted that soy isoflavone is known to comprise the polyphenolic isoflavonoids claimed herein and yeast β-glucan is known to contain the β-1,3/1,6-glucan claimed herein. ‘809 also states that the combination of soy isoflavone and β-glucan increased production of SCFA after both 6 and 24hours; and shifted the type of SCFA produced in the feces to favor propionate at the expense of other SCFA (see table 2 and column 8, lines 24-40). What is not taught is to add germinated seeds as done in present claim 7 to the compositions therein.
‘480 teaches that germinated seeds such as chia seed, rice, whole grain wheat etc. are beneficially added to add a prebiotic portion to a pet food (see claim 3 therein).
As noted above, it would have been obvious to one of skill in the art to modify the compositions of ‘809 and arrive at the present compositions as the difference is minor in merely changing amounts of agents to be included therein wherein ‘809 teaches a ratio of about 23:1 to about 7:1 of β-glucan:isoflavone and the present application has a range of about 1:1 to 5:1 of β-glucan:isoflavone. This modification of amounts is well within the purview of a skilled artisan looking for new compositions. Modifying the amounts of the active agents is seen to be obvious absent a showing of unexpected results which are commensurate in scope with the claims. Likewise, it would have been obvious to add the additional germinated seeds of ‘480 into the compositions of ‘809 as they are taught to be effective prebiotic agents wherein ‘809 uses beet pulp and citrus acid as prebiotics. It would be obvious to add an additional or substitute one prebiotic for another absent a showing of unexpected results.
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 1-6, 9-16, and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,842,809. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are drawn to very similar pet food compositions.
The claims of the present application are drawn to pet food compositions comprising β-1,3/1,6-glucan and polyphenolic isoflavonoids having a ratio of about 1:1 to 5:1. Dependent claims provide for various ratios such as about 2:1; and to include additional prebiotic component such as beet pulp or citrus pulp or combinations thereof. Also claimed are limitations on the amount of the agents in the composition based on the total weight of the composition such as the β-glucan in an amount from 0.1-10 or 0.3-5wt% and the isoflavonoids are from about 0.01-1 or 0.05-0.5wt%. Applicants also provide limitations which would occur after administration of the composition – such as that after 3 days of administration an increase in a weight ratio of propionate to BSCFA and an increase in weight ratio of SCFA to BSCFA in the feces occurs.
‘809 is drawn to pet food compositions comprising from 0.03 wt% soy isoflavone (see claim 8); 0.4 wt% β-glucan (see claim 9) and various other ingredients including beet and citrus pulp (see claim 5-6). As set forth above – it is noted that soy isoflavone is known to comprise the polyphenolic isoflavonoids claimed herein and yeast β-glucan is known to contain the β-1,3/1,6-glucan claimed herein. ‘809 also states that the combination of soy isoflavone and β-glucan increased production of SCFA after both 6 and 24 hours; and shifted the type of SCFA produced in the feces to favor propionate at the expense of other SCFA (see claim 1-3 therein). What is not taught is the exact ratio claimed herein.
It would have been obvious to one of kill in the art to modify the compositions of ‘809 and arrive at the present compositions as the difference is minor in merely changing amounts of agents to be included therein wherein ‘809 teaches a ratio of about 23:1 to about 7:1 of β-glucan:isoflavone and the present application has a range of about 1:1 to 5:1 of β-glucan:isoflavone. This modification of amounts is well within the purview of a skilled artisan looking for new compositions. Modifying the amounts of the active agents is seen to be obvious absent a showing of unexpected results which are commensurate in scope with the claims. Moreover, ‘809 claims an increase in propionate content of the SCFA after 6 and 24 hours 24 hours, it would be obvious they would also be increased comparatively after 3 days, since the same or substantially similar compositions are administered to the same population as done herein.
Conclusion
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693