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 46 have been amended.
Claims 46-87 are pending.
Claims 1-45 are cancelled.
Claims 51-55 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 46-50 and 56-57 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18, and 23 of copending Application No. 17/040,445 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application teaches a composition for an adult dog comprising methionine an cysteine (claim 1). The ratio of methionion:cysteine is 1:2.5 w/w. Methionine is in a concentration of 0.71 g/100kcal (claim 23), therefor the cysteine, when following the ratio, would be at an amount of 1.78 g/100kcal. The composition is administered to a dog (claim 18).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). In the instant case, the copending application recites a narrower “species” of values compared to the broad “generic” ranges recited in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 46-50 and 56-57 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 46, recites “administering an edible pet food product”, however it does not state how or what the composition is administered to. For instance, it could be interpreted as being administered directly to the companion animal or being administered to the companion animal’s food bowl. It is therefor indefinite due to the multiple interpretations.
The dependent claims fall therewith.
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.
Claims 46, 50, 56, and 57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pet Medical Center (7 Healthy People Foods to Feed Your Dog. 2018.) as evidenced by NUTRITIONVALUE. (Egg, hard-boiled, cooked, whole. Via wayback machine 2015.).
Regarding claim 46, Pet Medical Center teaches that feeding your dog a hardboiled egg can be beneficial in giving dogs protein and important vitamins (page 2, bullet 1). A hardboiled egg has the species of amino acids, methionine and cysteine, in the specified values as recited by claim 46 as evidenced by NUTRITIONVALUE. NUTRITIONVALUE teaches that an cooked egg per 100g has 155 calories, 0.392 g methionine and 0.292 g cysteine. When converted to g/1,000 kcal the values are 2.53g/1000kcal of methionine and 1.88g/1000kcal of cysteine. Note, “Calories” as listed on the nutrition label correlate to “kcal”.
Note, since the prior art is doing the same step, administering, with the same species and values, methionine and cysteine, it would result in the same result of “modulating an oral microbiota of a companion animal” unless proven otherwise.
Regarding claim 50, A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed. Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.") MPEP 2111.04 The wherein clause merely characterizes the results of those steps. Therefore, we determine that the "wherein" clause is not entitled to weight in construing the claim. This is in regards to “wherein modulating the oral microbiota comprises increasing the uber of species of or prevalence of bacteria associated with good oral health”. Furthermore, the prior art teaches all steps, administering, and the species in their respective values, methionine and cysteine, so it would perform the same action unless proven otherwise.
Regarding claim 56, Pet Medical Center, evidenced by NUTRITIONVALUE, teaches the composition is administered in the same concentrations as claimed by Applicant, which is therefor an amount effective to improve oral health of the animal, unless proven otherwise.
Regarding claim 57, Pet Medical Center teaches that feeding your dog a hardboiled egg can be beneficial in giving dogs protein and important vitamins (page 2, bullet 1).
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.
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 46, 50, 56, 57 are rejected under 35 U.S.C. 103 as being unpatentable over Pet Medical Center (7 Healthy People Foods to Feed Your Dog. 2018.) in view of NUTRITIONVALUE. (Egg, hard-boiled, cooked, whole. Via wayback machine 2015.).
Regarding claim 46, Pet Medical Center teaches that feeding your dog a hardboiled egg can be beneficial in giving dogs protein and important vitamins (page 2, bullet 1).
Pet Medical Center does not teach the amounts of methionine and cysteine present in the egg.
NUTRITIONVALUE teaches that an cooked egg per 100g has 155 calories, 0.392 g methionine and 0.292 g cysteine. When converted to g/1,000 kcal the values are 2.53g/1000kcal of methionine and 1.88g/1000kcal of cysteine. Note, “Calories” as listed on the nutrition label correlate to “kcal”.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate an egg with the cysteine and methionine values cited above. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because those are the nutritional values of a normal egg.
Note, since the prior art is doing the same step, administering, with the same species and values, methionine and cysteine, it would result in the same result of “modulating an oral microbiota of a companion animal” unless proven otherwise.
Regarding claim 56, Pet Medical Center, in view of NUTRITIONVALUE, teaches the composition is administered in the same concentrations as claimed by Applicant, which is therefor an amount effective to improve oral health of the animal, unless proven otherwise.
Regarding claim 57, Pet Medical Center teaches that feeding your dog a hardboiled egg can be beneficial in giving dogs protein and important vitamins (page 2, bullet 1).
Regarding claim 50, A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed. Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.") MPEP 2111.04 The wherein clause merely characterizes the results of those steps. Therefore, we determine that the "wherein" clause is not entitled to weight in construing the claim. This is in regards to “wherein modulating the oral microbiota comprises increasing the uber of species of or prevalence of bacteria associated with good oral health”. Furthermore, the prior art teaches all steps, “administering”, and the species in their respective values, methionine and cysteine, so it would perform the same action unless proven otherwise.
Claims 46-50, 56, 57 are rejected under 35 U.S.C. 103 as being unpatentable over Pet Medical Center (7 Healthy People Foods to Feed Your Dog. 2018.) and NUTRITIONVALUE. (Egg, hard-boiled, cooked, whole. Via wayback machine 2015.) in view of HOWE (Food for Pregnant Dogs. 2018.).
Pet Medical Center and NUTRITIONVALUE teach Applicant’s invention as discussed above.
Regarding claims 47-49,Pet Medical Center and NUTRITIONVALUE do not specifically teach how many times to administer the egg.
Regarding claims 47-49, HOWE teaches that giving dogs hard boiled eggs every other day for 2 weeks and every day for 1 week is beneficial as it gives the dog protein (page 4, paragraph 2), which would be at least 5 times and at least once daily.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate administering the egg multiple times, such as at least 5 times. The person of ordinary skill in the art would have been motivated to make those modifications, because it is safe and provides the dog protein and important vitamins, and reasonably would have expected success because all references are in the same field of endeavor such as administering eggs to dogs.
Response to Arguments
Applicant argues, the claimed values show unexpected results. As an initial matter, increasing methionine levels from 0.55g/1,000kcal (Diet B) to 0.71g/1,000kcal (Diet C) increases the prevalence of many bacterial species associated with good oral health (e.g., Bacteroidetes, Proteobacteria, and Fusobacteria), see Example 1 at page 26, Table 2 within the present application. Surprisingly, Diet A comprising the highest amount of methionine and the lowest amount of cysteine uniquely promotes an increased prevalence of bacteria associated with good oral health while simultaneously reducing the prevalence of bacteria associated with poor oral health ( e.g., Firmicutes, Actinobacteria, Synergistetes, WS6, Spirochaetae, and Chlorobi), see Table 2 and page 27, lines 21-25 of the present application. Therefore, administering a pet food product comprising the claimed amounts of methionine and cysteine yields unexpected advantages in modulating the oral microbiome that are not suggested by Fahim.
In order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In the instant case, the prior art teaches the claimed amounts of methionine and cysteine, see rejection above. Therefor it would have the same properties of the claimed invention unless proven otherwise.
For a complete discussion of unexpected results, Applicants are referred to MPEP 716.02 et seq.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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