DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, 6, 13 and 22-26, in the reply filed on 1/13/25 is acknowledged.
Applicant has amended withdrawn claims 16-21 so that they are now drawn to a composition, not a method. The composition belongs in elected Group I. Accordingly, these composition claims are now being placed in elected Group I. If these claims are amended back to a method, they will be withdrawn from consideration as being directed to a non-elected invention, e.g., election by original presentation. See 37 CFR 1.142(b) and MPEP § 821.03.
Claims 1-4, 6, 13 and 16-26 are currently under examination.
Claim Interpretation
Regarding claim 1’s preamble of “for the treatment of an enteric disease in animals through modulation of the TLR pathway” and claim 2’s preamble of “for the treatment of disease in animals … wherein the disease being treated is coccidiosis”, and claim 16’s “for treatment of an animal for subclinical or clinical coccidiosis through modulation of at least one TLR pathway”, these phrases have been considered but are not given patentable weight because they are statements of intended uses of the claimed product/composition. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone (MPEP 2111.02: Effect of Preamble). Further note that dependent claims may also be non-limiting because they fall within the intended use phrases for the reason further discussed below. Nonetheless, if the prior art teaches the same structure(s), then the prior art would be capable of meeting the intended use limitations.
Claim Rejections - 35 USC §112, 2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
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 1-4, 6, 13 and 16-26 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is rejected as being indefinite because it recites the abbreviation of “TLR”. An abbreviation should be spelled out the first time it appears in a claim. An abbreviation should be preceded in its first occurrence by the specific identity of the entity which said abbreviation is intended to represent. A review of the specification does not define the meaning of “TLR” and therefore, the abbreviation may have multiple meanings (e.g., Toll-Like Receptor, T-lymphocyte recognition, etc.) which leads to confusion of the precise definition. As noted in the quotation above, the specification should have clear and concise support for the claimed term “TLR” because otherwise, Applicant may change its intended meaning throughout different points in prosecution.
Claim 1 is also vague and indefinite because it recites “the composition comprising effective amounts of an algal biomass as an ingredient of finished feed”. This is vague and confusing because it is unclear if the feed is part of the claimed composition. Does the claimed composition actually contain the feed or is the claim reciting an ingredient to be used in feed? The wording is unclear. Appropriate clarification and/or correction is required.
Claims 4, 6, and 10-11 recite, in part, “wherein the algal biomass is fed to the animal” and thus, are rejected as being indefinite because they imply an active, physical, or tangible process step of feeding an animal but the claimed invention is directed to a product or composition of matter. In other words, a claimed invention should not be drawn to two different statutory categories of invention (i.e., in the instant case, both a product and process of using are being claimed) because it renders the point of novelty unclear and the examination analysis of product versus process are vastly different (hence, a restriction requirement was required). “For processes, the claim limitations will define steps or acts to be performed. For products, the claim limitations will define discrete physical structures or materials” (MPEP 2103(I)(C)). In an alternative interpretation, it is not clear if these phrases of “wherein the algal biomass is fed to the animal” were intended to be an embodiment of the preamble’s intended use. In the latter case, if they were intended as such, for the reasons discussed in the claim interpretation above, then they would not carry patentable weight because they are part of and/or merely further describing the preamble. Appropriate clarification and correction are requested.
Claim Rejections - 35 USC §101, Subject Matter Eligibility
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 1-4, 6, 13 and 16-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it reads on a product of nature.
The bacteria recited in the composition are products of nature. Even though isolation changes a bacterium from its natural state, the resultant difference is no enough to render the bacteria markedly different because it is the same as wild-type bacteria. There is no indication that mixing these bacteria has any changes to the structure of either component.
STEP 1: Is the claim directed to a process, machine, manufacture, or a composition of matter?
YES, the claims are directed to a composition of matter.
After a review of the specification, there is no indication that the claims have any characteristics that are different from what occurs in nature. For example, the specification discloses:
“More particularly, the disclosed inventive concept relates to a method and treatment using a natural feed treatment compound” (see pre-grant publication at ¶ [0001]).
“The compound of the disclosed inventive concept is produced from one or more bacterial strains, many of which are naturally occurring in various environments” (see pre-grant publication at ¶ [0001], [0021]-[0028]).
“The disclosed inventive compound is a natural product and thus has no adverse environmental impact” (see pre-grant publication at ¶ [0010]).
“providing both disease prevention and disease treatment in an all-natural compound” (see pre-grant publication at ¶ [0012]).
The claimed invention is directed to the judicial exceptions of a law of nature and/or natural phenomena without significantly more nor has a markedly different characteristic. To show a marked difference, the characteristic(s) must be changed as compared to nature. Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements. Note that merely because a particularly combination of bacteria is not found to co-exist together in nature is not the standard for demonstrating a marked difference (MPEP 2106.04).
With respect to claims 1-4, 6 and 13, as stated in the 112, second paragraph rejection it is not clear that feed is included in the claimed composition. See the 112, second paragraph rejection set forth above.
Claim Rejections - 35 USC §103, Obviousness
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claim(s) 1-4, 6, 13 and 16-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sommer et al (US 2018/0273940; provided by Applicants).
Sommer et al composition for the treatment of disease (para {0061}: "a composition for carrying out an ex vivo or in vitro a method of treatment of a microbial infection of a substrate, wherein the microbial infection is caused by microbes") in animals (para (0068): “treating a pathogenic bacterial infection in a human or animal subject caused by bacteria") through modulation of the pathway (para [0402]: "the microbiome composition can modulate therapy outcomes”, para {0558}: “immune checkpoint inhibitors include, without limitation, agents targeting immune checkpoint proteins and pathways"), the composition comprising effective amounts of an algal biomass (para (0150): "the microbes are algae"; para [0301]: “in an alternative, instead the microbes are algal cells”) as an ingredient of finished feed (para [0245], food/foodstuff), the algal biomass comprising at least two bacteria selected from the group consisting of Algoriphagus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., Sphingomonas sp., and Variovorax sp. (para [0598], pg 38 and 40: "the composition of Paragraph 1 or Paragraph 2, wherein the at least one isolated or purified population bacteria or the at least two isolated or purified populations of bacteria belong to the species, subspecies or bacterial strains selected from the group consisting of ... sphingomonas aquafilis"; para [0893], Table 1: bosea - pg 51 col 4, brevundimonas - pg 51 col 5, desulfovibrio - pg 54 col 3, microbacterium - pg 55-56 col 3, variovorax - pg 58 col 2). Whereas Sommer does not disclose a single example or specific embodiment comprising all aforementioned elements as well as that the said pathway is a TLR (toll-like receptor) pathway, in view of the above disclosure, it would have been obvious for the person of ordinary skill in the art to design the said composition in the course of routine experimentation in order to better treat the subject in need and expect an inherent modulation of the said TLR pathway. Sommer discloses a composition for the treatment of disease in animals (para [0061], [0068]), the composition including an algal biomass (para [0150], [0301]) as a portion of finished feed (para [0245)), the algal biomass consisting essentially two or more bacteria selected from the group consisting of Algoriphagus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., Sphingomonas sp., and Variovorax sp. (para [0598], pg 38 and 40 - sphingomonas; para [0893], Table 1: bosea - pg 51 col 4, brevundimonas - pg 51 col 5, desulfovibrio - pg 54 col 3, microbacterium - pg 55-56 col 3, variovorax - pg 58 col 2). Whereas Sommer does not disclose a single example or specific embodiment comprising all aforementioned elements, in view of the above disclosure, it would have been obvious for the person of ordinary skill in the art to design the said composition in the course of routine experimentation in order to treat the subject in need. Most importantly, the claimed composition ‘for treatment of disease in animals through modulation of the TLR pathway’ is an intended use only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. A “physiologically acceptable carrier” reads on water and therefore would be inherent in the preparation of the compositions.
With respect to claims 4, 13 and 17-26 it is noted that in these claims ‘is fed to in [X] amount” does not require the composition to contain this amount. See 112, second paragraph above which recites:
, “wherein the algal biomass is fed to the animal” and thus, are rejected as being indefinite because they imply an active, physical, or tangible process step of feeding an animal but the claimed invention is directed to a product or composition of matter. In other words, a claimed invention should not be drawn to two different statutory categories of invention (i.e., in the instant case, both a product and process of using are being claimed) because it renders the point of novelty unclear and the examination analysis of product versus process are vastly different (hence, a restriction requirement was required). “For processes, the claim limitations will define steps or acts to be performed. For products, the claim limitations will define discrete physical structures or materials” (MPEP 2103(I)(C)). In an alternative interpretation, it is not clear if these phrases of “wherein the algal biomass is fed to the animal” were intended to be an embodiment of the preamble’s intended use. In the latter case, if they were intended as such, for the reasons discussed in the claim interpretation above, then they would not carry patentable weight because they are part of and/or merely further describing the preamble.
For this rejection, the alternative interpretation is being used, e.g., intended use.
Claim(s) 4, 13, 17-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sommer et al (US 2018/0273940; provided by Applicants), as applied to claims 1-3 and 16 above, in view of Dahl et al (WO 2020/132318; 6/25/20).
The teachings of Sommer et al are set forth above. It is noted that in these claims ‘is fed to in [X] amount” does not require the composition to contain this amount. See 112, second paragraph above which recites:
, “wherein the algal biomass is fed to the animal” and thus, are rejected as being indefinite because they imply an active, physical, or tangible process step of feeding an animal but the claimed invention is directed to a product or composition of matter. In other words, a claimed invention should not be drawn to two different statutory categories of invention (i.e., in the instant case, both a product and process of using are being claimed) because it renders the point of novelty unclear and the examination analysis of product versus process are vastly different (hence, a restriction requirement was required). “For processes, the claim limitations will define steps or acts to be performed. For products, the claim limitations will define discrete physical structures or materials” (MPEP 2103(I)(C)). In an alternative interpretation, it is not clear if these phrases of “wherein the algal biomass is fed to the animal” were intended to be an embodiment of the preamble’s intended use. In the latter case, if they were intended as such, for the reasons discussed in the claim interpretation above, then they would not carry patentable weight because they are part of and/or merely further describing the preamble.
However, Dahl is cited to teach these were common amounts in the art.
Dahl discloses Algal feed ingredient wherein the disease being treated is coccidiosis (abstarct; pg 2 In 25- 29). Both Sommer and Dahl disclose treatment of poultry (Sommer, para [0152]; Dahl, pg 2 In 25-29) with combination of two or more algae (Sommer, para [0598]; Dahl, pg 7 In 5-8) as well as antimicrobial activity of the utilized compositions (Sommer, para [0061], [0068); Dahl, pg 2 In 25-29), it would have been obvious to one having ordinary skill in the art to combine the teachings of Sommer and Dahl, and design the said disease-treating composition, as disclosed in Sommer, while utilizing the said composition for coccidiosis treatment, as disclosed in Dahl, in order to better treat the subject in need. Sommer discloses the composition, but does not specifically disclose wherein the algal biomass is fed to the animal in an amount from about 60.0 g per ton of finished feed to about 150.0 g per ton of finished feed. However, Dahl discloses wherein the algal biomass is fed to the animal (pg 5 In 23-25) in an amount from about 60.0 g per ton of finished feed to about 150.0 g per ton of finished feed (pg 4 In 7-10: "a dried algal biomass may be incorporated into poultry feed as a nutritional ingredient at levels of from about 0.01 wt.% (0.2 pounds dried algal biomass/ton feed) to about 1.0 wt.% (20 pounds dried algal biomass/ton feed), based on the total weight of the poultry feed composition"; i.e., 100-10,000 g/ton or 0.22-22 Ibs/ton). In view that both Sommer and Dahl disclose treatment of poultry (Sommer, para [0152]; Dahl, pg 2 In 25-29) with combination of two or more algae (Sommer, para [0598]; Dahl, pg 7 In 5-8) as well as antimicrobial activity of the utilized compositions (Sommer, para [0061], [0068]; Dahl, pg 2 In 25-29), it would have been obvious to one having ordinary skill in the art to combine the teachings of Sommer and Dahl, and design the said disease-treating composition, as disclosed in Sommer, while utilizing the certain amount of algal biomass per ton of finished feed, as disclosed in Dahl, in order to better treat the subject in need. Dahl further discloses wherein the algal biomass is fed to the animal (pg 5 In 23-25) in an amount from about 60.0 g per ton of finished feed to about 100.0 g per ton of finished feed (pg 4 In 7-10; i.e., 100-10,000 g/ton or 0.22-22 Ibs/ton). Sommer further discloses wherein the algal biomass (para [0150], {0301]) includes three bacteria (para (0598), pg 38; the latter disclosure of two or more bacteria inherently implies inclusion of three bacteria In the said composition). Sommer further discloses at least two bacteria (para [0598], pg. 38) as well as the first and the second bacteria and altering the ratio of different bacteria (para [0249]); and Dahl further discloses the total bacteria content is between about 100 g to 10,000 g par tan of finished feed (pg 4 In 7-10). Whereas neither Sommer nor Dahl discloses a single example or specific embodiment in which the first bacteria represent between about 40.0 g to about 50.0 g per ton of finished feed, the second bacteria represent between about 25.0 g to about 35.0 g per ton of finished feed, and the third bacteria represent between about 1.0 g and 10.0 g per ton of finished feed, in view of the above disclosure, it would have been obvious to one having ordinary skill in the art to combine the teachings of Sommer and Dahl, and design the said disease-treating composition, as disclosed in Sommer, while adjusting the certain amount of bacteria per ton of finished feed to be within the specified ranges, as disclosed in Dahl, in order to better treat the subject in need. Sommer further discloses wherein the three bacteria include Brevundimonas sp., Sphingomonas sp., and Microbacterium sp. (para [0598], pg 40 - sphingomonas; para [0893], Table 1: pg 51 col 5 - brevundimonas: pa 55-56 col 3 - microbacterium).
Claims 1-4, 6, 13 and 16-26 are rejected under 35 U.S.C. 103 as being unpatentable over:
(1°) Ulsemer (US 2023/0277607 A1, with a PCT filing date of 07/14/2020) in view of
(2°) Tate (The Effects of Plant Growth Substances and Mixed Cultures on Growth and Metabolite Production of Green Algae Chlorella sp.: A Review, 2013),
(3°) Chaudhary (Effect of Sphingomonas sp., as a Probiotic on Survival, Growth and Biochemical Constituents of Vibrio anguillarum Challenged Labeo rohita Fingerlings, 2020),
(4°) Ushakova (Microbacterium oxydans, a Symbiont of Djungarian Hamster Which Displays Probiotic Properties, 2004); all references provided by Applicants.
Ulsemer’s general disclosure relates to a composition comprising modified non-pathogenic microorganisms (see abstract & ¶ [0001]). Non-pathogenic microorganisms especially food graded microorganisms displaying a specific structure (e.g., oligosaccharide, peptide, proteins) on their surface have a broad application potential in food and medicine (see ¶ [0002], [0005], [0282]-[0283]). Ulsemer teaches a mixture of microorganisms are naturally occurring and are used as an active ingredient in a pharmaceutical composition (see ¶ [0067]-[0073], [0141], [0144]). From a laundry list, Ulsemer does mention wherein said microorganism is selected from the group that includes: Algoriphagus sp., Bosea sp., Brevundimonas sp., Desulfovibrio sp., Microbacterium sp., Sphingomonas sp., and Variovorax sp. (see ¶ [0279]-[0280]).
However, Ulsemer does not particularly teach: the algal biomass comprising the claimed bacteria combination that includes two or three of the claimed bacteria.
Regarding the Brevundimonas and algal biomass, Tate discloses that microalgae provide a number of valuable products that includes food supplements, animal feed additives, and aquaculture feed wherein some important bioproducts produced by microalgae include the high-value carotenoid astaxanthin (see page 417, right col.). Tate teaches the co-culture of Chlorella cells with Brevundimonas sp. wherein the bacteria appeared to promote the growth of the algae (see abstract & page 423, left col.).
Regarding the Sphingomonas sp., Chaudhary discloses that “probiotics are live microbial cultures when added to feed or rearing water, result in improved health status and growth of host animals” (see page 1, left col.). Probiotics are microbes to enhance the nutritional values of food (see page 6, left col.). Chaudhary teaches Sphingomonas sp. as a probiotic bacterium and enhanced survival rate (see abstract, & page 4: Results, & page 7: Conclusion). Chaudhary discloses feed additive or supplement may include microalgae (see page 1, right col.).
Regarding the Microbacterium, Ushakova discloses that “Probiotics stimulate uptake and digestibility of feed, thereby providing intensive growth and development in animals” (see page 555, left col.). Ushakova teaches the isolated bacterium of Microbacterium species displayed probiotic properties which manifested itself in increased overall body weight and weight of several organs and stimulation of both cell-mediated and humoral immunities (see abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ or combine the bacterial strains of Brevundimonas, Sphingomonas, and Microbacterium as respectively taught above by Tate, Chaudhary, and Ushakova into the composition of Ulsemer. The ordinary artisan would have been motivated to do so is because each of the bacterial strains and their functional benefits are already known and individually taught in the prior art. Moreover, the MPEP 2141(III) provides examples of rationales that may support a conclusion of obviousness include:
(a) combining prior art elements according to known methods to yield predictable results; (e) obvious to try – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; or
(g) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Accordingly, it would have been reasonable for an ordinary artisan to select and use each of the claimed bacterial strains for its documented probiotic or beneficial advantages/effects. The ordinary artisan would have had a reasonable expectation of success because all of the references are in the same field of endeavor directed to compositions comprising bacterial microorganisms.
Regarding the claimed concentration or amount, the MPEP 2144.05(II) states that: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Therefore, one of ordinary skill in the art would recognize the claimed concentration or amount is a result effective variable dependent on various factors. For example, Ulsemer discloses that “The appropriate dosage, or therapeutically effective amount, will depend on the condition to be treated, the severity of the condition, prior therapy, and the patient’s clinical history and response to the therapeutic agent. The proper dose can be adjusted according to the judgment of the attending physician such that it can be administered to the patient one time or over a series of administrations. The pharmaceutical composition can be administered as a sole therapeutic or in combination with additional therapies as needed” (see ¶ [0189]). This is motivation for someone of ordinary skill in the art to practice or test the parameter values widely to find those that are functional or optimal which then would be inclusive or cover those values as instantly claimed. Absent any teaching of criticality by the Applicant concerning the claimed concentration or amount, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization (MPEP 2144.05 II).
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 1-4, 6, 13 and 16-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 17/576,444 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both co-pending ‘444 and the instant claims are obvious variants or minor differences of one another. The co-pending claims include the same bacteria in the composition in the same formulations as instantly claimed. They are drawn to a product-by-process. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 13 and 16-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-29 of copending Application No. 18/988,752 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because because both co-pending ‘752 and the instant claims are obvious variants or minor differences of one another. The co-pending claims include the same bacteria in their methods as the composition as instantly claimed. The composition in the co-pending claims are drawn to a product-by-process. “The patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). This application was not restricted from ‘752 so a double patenting rejection is applicable.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Thursday from 8:00 AM-6:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gary Nickol, can be reached on (571) 272-0835.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 1/29/25