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
The present application is a National Stage entry of International application PCT/US2023/015599 filed 03/20/2023, which claims the benefit of Provisional US application 63322344 filed 03/22/2022.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 09/18/2024, in the matter of Application N° 18/848,152. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1, 3-5, 7-12, 16-20, 22, 24-25, 37, and 39 are pending.
Claims 1, 3-5, 7-12, 16-20, 22, 24-25, 37, and 39 are presented for examination and rejected as set forth below.
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, 3-5, 7-12, 16-20, 22, 24-25, 37, and 39 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, 7-9, 11, 22, 24-25 recite the term “about” to describe numerical values, which is indefinite because it is an imprecise definition of a value, which is not further defined in the Application (e.g., the Specification does not provide a definition that provides consistent interpretation of the term; see [0051]: “As used herein, the term "about", when referring to a numerical value or range of values, allows for a degree of variability in the value or range or values, for example, within 10%, or within 5% of a stated value or of a stated limit of a range.”). The Examiner suggests “about” should be removed and considers the claim values as if the term “about” was not present. See MPEP 2173.05(b)(i).
All other claims that depend from claim 1 are additionally rejected.
Claims 16 and 38 recite “substantially free” (i.e., mostly free), which is not defined by the Specification and is considered relative terminology (i.e., substantially is not defined by numerical amounts or some other descriptive characteristic). Therefore, “substantially free” as a modifier does not provide an understanding of the metes and bounds of the invention. Therefore, the Examiner will consider the claims without the term “substantially”, such that claim 16 is just “are free of any protrusions” and claim 39 is just “are free of dental calculus.”
Claim Rejections - 35 USC § 103
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.
Claims 1, 8, 24, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US20120184612A1), in further view of Torney (US20100003393A1) and Glen Axelrod (US20130247836A1), as evidenced by Notes and Sketches (2017).
Applicant’s claims are directed to an edible soft dental chew comprising: an edible body comprising astaxanthin, wherein the edible body has an average Shore A hardness of less than about 60. Applicant also recites a method of treatment (instant claims 24-25, 37, and 39).
Zhang teaches pet food compositions that comprise carotenoids (abstract) for dental health [0077], including a wide variety of formulations including a gravy, liquid, yogurt, powder, suspension, chew, treat (e.g., biscuit), or any other delivery form [0034], that represent forms of varying amounts of hardness.
Regarding claim 1: Zhang teaches compositions that comprise astaxanthin (Zhang – claim 1) in the form of an edible chew [0034].
Regarding claim 24: Zhang teaches a method of applying the oral chew once per day to an animal (Zhang – claim 20).
Regarding claim 39: Zhang’s method does not require the composition to be applied to teeth with dental calculus (i.e., tartar) (i.e., dental and gum health is a broadly stated application with no particular requirements of the patient population [0077]).
In summary, Zhang teaches an edible chew composition comprising astaxanthin, and a method of applying to an animal for general dental and gum health. Zhang’s composition can also be presented in a wide variety of formulations including a gravy, liquid, yogurt, powder, suspension, chew, treat (e.g., biscuit), or any other delivery form [0034], that represent forms of varying hardness. However, Zhang is silent on the Shore A hardness (instant claims 1 and 8) and does not teach plaque and/or calculus prevention/inhibition (instant claim 24).
Torney teaches edible pet chew compositions (abstract), in contrast to non-food dental chews [0008], that have a hardness of 33-1270 N (see discussion of Newton hardness vs. Shore A hardness further below) [0040-043, 0047-0052], that are described by the terms “softer” and “chewier” [0020], and further provides plaque and tartar removal [0017]. Thus, Torney teaches that softer, chewier texture of the present pet chew improves animal enjoyment and demonstrates enhanced oral care efficacy [0020]. As evidenced by Notes and Sketches, Shore A hardness is an alternate hardness test that is typically used to characterize softer plastics, elastomers and rubbers (pg 3), compared to the Newton-based testing of Torney.
Glen Axelrod, additionally, teaches a Shore A value of 40-90 [0042] (reads on less than 60 of instant claims 1 and 8), as suitable for pliable oral dog chewing use for dental treatment, including plaque and tartar treatment [0002-0010] (i.e., the reference is reasonably pertinent to the instant application that relates to oral dental chew compositions of a suitable Shore A hardness). Therefore, a PHOSITA would consider a Shore A value of 40-90 or less (i.e., according to the benefit described of softer chews by Torney [0020]), as suitable for dog chews. Additionally, Axelrod teaches incorporation of chicken by-product meal in order to ensure nutritional completeness [0054-0055].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Zhang to have a specific low Shore A hardness, as taught by Torney and Glen Axelrod, because Glen Axelrod teaches pliable oral dog chew toys with a Shore A value of 40-90, as suitable for safe dog dental treatment use [0002-0010], and Torney teaches edible pet chew compositions that have a softer, chewier texture to improve animal enjoyment and demonstrate enhanced oral care efficacy that provides motivation [0020], in contrast to non-food dental chews [0008] and/or similar products on the market [0020]. Thus, specifying a lower Shore A hardness value (i.e., softer) ensures this benefit. Furthermore, Zhang teaches a “chew” formulation from Zhang, where Zhang’s composition can also be presented in a wide variety of formulations including a gravy, liquid, yogurt, powder, suspension, chew, treat (e.g., biscuit), or any other delivery form [0034], that represent forms of varying hardness.
Further note, that Shore A hardness is one of many ways to measure hardness (see Torney, Notes and Sketches, and Glen Axelrod) and Torney demonstrates soft edible pet chews with beneficial properties, that are demonstrated as soft by a different hardness measure (i.e., measure in Newtons). The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus, Torney’s teaching of “soft” edible pet chews (also by the lower value range of Newton hardness), in contrast to non-food dental chews [0008], combined with Glen Axelrod, additionally, teaching a Shore A value of 40-90 [0042] (reads on less than 60 of instant claims 1 and 8), as suitable for pliable oral dog chewing use for dental treatment [0002-0010], provides the same effective teaching of Applicant’s limitation of an average Shore A hardness of less than about 60.
Claims 1, 3-5, 7-12, 16-20, 22, 24-25, 37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US20120184612A1), Torney (US20100003393A1), and Glen Axelrod (US20130247836A1), as evidenced by Notes and Sketches (2017), as applied to claims 1, 8, 24, and 39 above, and in further view of Xu (US20140044838A1), Scherl (US20140314819A1), and Herbert Axelrod (US5240720).
As discussed above, the combined Prior Art teaches an animal chew comprising astaxanthin of a suitable Shore A hardness and a method of treatment for dental plaque and tartar. However, the combined Prior Art does not teach the chicken meat and amount (instant claims 3-5, 7, 10, 17-20, and 22), the core/outer layer (i.e., coating) aspect (instant claims 9-12, 16-20, 22, and 25), a patient population with missing, deciduous (i.e., baby), or cracked teeth (instant claim 37).
Xu teaches 5%-33% meat ingredient (Xu – claim 1) that is made of poultry meat (Xu – claim 2) (i.e. reads on claims 3-5, 7, 10, 17-20, and 22), that provides a long-last chew, by achieving a chewy property, and also smells good for dogs [0022, 0027-0029]. Thus, the principle of adding a meat ingredient to soften tough rawhide material is also demonstrated (teaching the hardness reducing aspect of meat, as in claims 3-5) [0100]. With regard to the numerical range of the meat amount, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
Scherl teaches optional coatings (i.e., where the coating is inclusive of many types of ingredients, such as flavors, fats, oils, powders, and the like, and also active agents like lactic acid [0059-0061], which are materials that can also be found in the pet chew itself [0059-0061]) applied to a chew or applied to an edible toy (Scherl – claim 15, [0066]) for animal dental treatment [0011]. Thus, it would be obvious to separate the ingredients and/or property limitations taught as obvious by the combined Prior Art into a composition’s individual core and/or coating layer (as recited by instant claims 9-12, 16-20, 22, and 25).
Herbert Axelrod teaches a chew for a small puppy or an older dog with decayed molars (col 1, last paragraph). Furthermore, an animal’s preference for hardness varies based on age (col 1, lines 10-46), which is why modifiable texture and/or hardness is important (col 2, lines 34-39).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of the combined Prior Art, with the amount of poultry meat of Xu (reads on instant claims 3-5, 7, 10, 17-20, and 22), because Xu teaches this amount to be suitable for dogs, by solving issues of previous chews in providing a chewy property, that additionally provides a good smell to encourage use by dogs [0022, 0027-0029]. Furthermore, the combined Prior Art teaches proteins from meat (i.e., Zhang at [0036]) and chicken meat (i.e., Glen Axelrod at [0054-0055]), as nutritious and suitable for dog chews.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of the combined Prior Art by separating ingredients into a core and coating layer (reads on instant claims 9-12, 16-20, 22, 25), as taught by Scherl, because it provides oral accessibility of desired active agents, according to the layer the material is placed in [0064]. Furthermore, using a coating provides an alternative functional embodiment of the general teaching of a “chew” formulation from Zhang, where Zhang generally places no restriction on formulation type [0034]. Finally, it would be obvious to make the individual core and/or outer layer, according to properties obvious for the formulation as a whole (e.g., the core and/or outer layer could comprise astaxanthin active agent and/or maintain a suitable Shore A hardness for oral pet chewables, etc.) (as recited by instant claims 9-12, 16-20, 22, and 25).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the combined Prior Art, by treating small puppies and/or older dogs with damaged teeth (reads on instant claim 37), as taught by Herbert Axelrod, because Herbert Axelrod teaches completely digestible dog chews that are easily chewed (col 1, last paragraph; col 2 first paragraph), which are suitable for young and old dogs (col 1, last paragraph). Furthermore, an animal’s preference for hardness varies based on age (col 1, lines 10-46), which is why modifiable texture and/or hardness is important (col 2, lines 34-39).
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, 3-5, 7-12, 16-20, 22, 24-25, 37, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Torney (US20100003393A1) and Glen Axelrod (US20130247836A1), as evidenced by Notes and Sketches (2017):
claims 1-2, 11, 13, 15-37, 39-42, and 45-48 of copending Application No. 18/714,606 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach an edible chew with layers that comprise astaxanthin and one or more excipients and a method of treatment. The copending application differs only significantly by not including the Shore A hardness limitation.
This is remedied by Torney and Glen Axelrod, who teach the suitability of Shore A hardness of less than about 60 as suitable for oral dog care (via toys and/or edibles; see same rationale provided in the 103 rejection above). Glen Axelrod, additionally, teaches a Shore A value of 40-90 [0042] (reads on less than 60 of instant claims 1 and 8), as suitable for pliable oral dog chewing use for dental treatment, including plaque and tartar treatment [0002-0010]. One of ordinary skill in the art would have been motivated to modify the teachings of copending ‘606 because Torney teaches that softer, chewier texture of the present pet chew improves animal enjoyment and demonstrates enhanced oral care efficacy [0020] and specifying a lower Shore A hardness value promotes softness to ensure this benefit.
This is a provisional nonstatutory double patenting rejection
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 7/13/2026
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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