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 .
Election/Restrictions
Applicant's election without traverse of invention Group I, claims 1-12 and 16-18, in the reply filed on 04/02/2026 is acknowledged. Regarding the species election, it appears that there is a typographical error (“Lactobacillus lactis”) in Applicant’s reply, and that Applicant intended to elect the species Lactococcus lactis. In the interest of compact prosecution, bacteria species Lactococcus lactis and bacteria genus Lactococcus were examined.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Status
Claims 1-18 are pending (claim set as filed on 02/28/2024). Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/02/2026.
Claims 1-12 and 16-18 are currently under examination and were examined on their merits.
Priority
This application filed on 02/28/2024 claims priority to PCT application no. PCT/EP2022/074050, filed on 08/30/2022, and claims foreign priority to application no. EP21194077.0, filed on 08/31/2021. Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 03/05/2024 has been received and considered.
Claim Objections
Claim 10 is objected to because of the following informalities: “the method according to any claim 1” should read “the method according to claim 1” (lines 1-2).
Claim 11 is objected to because of the following informalities: “comprises in 104-1013 colony forming units/g” should read ““comprises 104-1013 colony forming units/g”” (line 8).
Appropriate correction is required.
Claim Rejections - 35 USC § 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 5, 9, and 16-18 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 5 and 16 recite “[t]he method according to claim 1, wherein the bacterial culture comprises or consists of one or more fermentative bacteria”, which renders the claim indefinite since it is unclear if Applicant is attempting to use Markush language and limit the alternatives accordingly. The language ‘consisting of’ appears to indicate Markush language, however, Markush language cannot recite comprising language since Markush language requires using a closed group (see MPEP 2173.05(h)). Thus, if Applicant is attempting to limit the species using Markush language, then Applicant should not use ‘comprising’ language.
Claim 9 recites “the pH of the fermentation medium decreases to no more than 5.5” (lines 12-13) which renders the claim indefinite since it is unclear if the pH after the decrease should be 5.5 or higher, or if the pH should be 5.5 or lower.
Claim 17 recites “the concentrated bacterial culture” (line 2) which is indefinite for lacking antecedent basis because ‘concentrated’ is not recited within the claim or in claim 1 from which claim 17 depends.
One of ordinary skill in the art would not be able to determine the metes and bounds of claims 5, 9, and 16-17, and thus, could not clearly determine how to avoid infringement of the claims.
Claim 18 is further rejected since the claim does not clarify the indefinite language in claim 17.
In the interest of compact prosecution, claims 5, 9, and 16-18, are interpreted to the broadest embodiment claimed.
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 1-12 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yde et al. (WO2020109567A1, published on 06/04/2020), hereinafter ‘Yde’.
Yde’s general disclosure relates to a process for obtaining a biomass composition of a bacterium strain with bactericidal activity which inhibits or kills various pathogenic bacteria (see entire document, including abstract).
Regarding claim 1, pertaining to the method, Yde teaches a method of preparing a bacterial culture (see Examples 1 and 2 on page 12 and claim 1) comprising: (a) culturing fermentative bacteria in a fermentation medium to obtain a bacterial culture (claim 1 step a; see Examples 1 and 2), wherein the fermentation medium has a pH lower than 6.0 at termination of the fermentation (see claim 1 step b; see Example 2, lines 18-19 ). The Examiner notes that ‘termination of fermentation’ is not clearly defined in the instant specification (page 5, lines 13-21). The specification describes the example wherein the fermentation process is ended when the bacterial culture “is processed as a non-fermentative step, such as concentration, freezing, drying etc” (specification, page 5, lines 13-17). Since Yde’s culture has a pH of below 5 before separating the biomass (see claim 1 steps b and d; see Example 2), Yde’s teachings read on instant claim 1 step (a).
Yde teaches adjusting the pH to a pH of 6.5 after the fermentation (see claim 1 step f, and claim 11; see Example 2). It is noted that the instant specification discloses wherein the adjustment of pH can be carried out on a concentrated bacterial culture” (page 6, lines 26-30).
Regarding claim 2, pertaining to the method according to claim 1, Yde teaches the method further comprising concentrating the bacterial culture by a one-step concentration method to obtain a concentrated bacterial culture (see claim 1 step d, and claim 6; see Example 2 on page 12, lines 21-22), and: freezing the concentrated bacterial culture to obtain a frozen bacterial culture (see claim 1 step h; see Example 2 on page 12); and removing water from the concentrated bacterial culture or the frozen bacterial culture to obtain a dried bacterial culture (see claim 1 step h; see Example 2 on page 12, line 26).
It is noted that the instant specification defines one-step concentration “as a concentration step that produces a concentrated bacterial culture in one step, and wherein the cells are maintained in suspension during the entire concentration step”, and further discloses that “[f]or the avoidance of doubt, a one-step concentration method does not include the two step method of (i) formation of a pellet of bacterial cells and (ii) resuspension of said cell pellet” (specification, page 7, lines 2-7). It is noted that Yde is silent on resuspending the separated biomass and recites a “biomass concentrate” after centrifugation (see Example 2, line 22). As such, Yde’s teachings read on the instant one-step concentration method.
Regarding claim 3, pertaining to the method according to claim 1, Yde teaches the method further comprising concentrating the bacterial culture by a one-step concentration method by a technique selected from centrifugal separation and filtration to obtain a concentrated bacterial culture (page 6, lines 17-20; see claim 1 step d and claim 6; see Example 2 on page 12).
Regarding claim 4, pertaining to the method according to claim 2, Yde teaches wherein the method comprises the step of removing water (see claim 1 step h), wherein the step of removing water is carried out by a technique selected from freeze drying and spray drying (page 7, line 6; see Example 2).
Regarding claim 5, please note the elected genus of Lactococcus under Election/Restriction above, and further note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the method according to claim 1, Yde teaches wherein the bacterial culture comprises one of the fermentative bacteria selected from the genera Lactococcus and Lactobacillus (page 5, line 31 - page 6, line 4; see claim 8 and Example 2).
Regarding claim 6, pertaining to the method according to claim 1, Yde teaches wherein the fermentation medium comprises (i) a carbohydrate (“glucose”; see Example 1, line 10, on page 12); and (ii) nitrogen sources (“peptone”, “meat extract”, “yeast extract”, see Example 1, line 10, on page 12).
Regarding claim 7, pertaining to the method according to claim 6, Yde teaches wherein the medium comprises a carbohydrate (see Example 1, line 10, on page 12), wherein (i) the carbohydrate is a monosaccharide (“glucose”; see Example 1, line 10, on page 12), and (ii) the total concentration of the carbohydrate is about 2% w/w (see Example 1, line 10, on page 12).
Regarding claim 8, pertaining to the method according to claim 1, Yde teaches the method further comprising concentrating the bacterial culture by a one-step concentration method to obtain a concentrated bacterial culture (page 6, lines 17-20; see claim 1 step d, and claim 6; see Example 2 on page 12), and adding a protective compound to the concentrated bacterial culture, wherein the protective compound is cryoprotectants (see Example 2 on page 12, lines 24-26).
Regarding claim 9, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the method according to claim 1, Yde further teaches wherein (ii) said fermentation is at ambient temperature which reads on the instantly recited “about 25°C” (see Example 1, line 14 on page 12).
Regarding claim 10, pertaining to the method according to claim 1, Yde teaches wherein adjusting the pH comprises adding the base sodium hydroxide (see Example 2 on page 12, line 23).
Regarding claim 11, pertaining to the method according to claim 2, Yde teaches wherein the method comprises removing water from the concentrated bacterial culture or the frozen bacterial culture to obtain a dried bacterial culture (see claim 1 step h and Example 2, line 26).
Claim 11 recites the following properties of the obtained dried bacterial culture: (i) has a water activity (aW) of 0.01-0.8, (ii) is in form of a granulate or powder, (iii) comprises 104-1013 colony forming units/g (CFU/g) dried bacterial culture, (iv) comprises a content of viable fermentative bacteria of 104-1013 CFU/g dried bacterial culture after storage for 16 weeks at 30°C and aw= 0.3, and (v) exhibits a loss of viability of less than 4 log units as measured by CFU/g after storage for 16 weeks at 30 °C and aw= 0.3 (lines 3-16).
It is noted that the properties of the obtained dried bacterial culture implicitly result from performing the claimed method. Yde teaches the method of claim 11 and as such inherently teaches the recited properties of the obtained dried bacterial culture in claim 11.
Yde further teaches wherein the dried bacterial culture exhibits one or more of the following properties: (ii) is in the form of a granulate or powder (page 7; lines 5-7; page 11, lines 19-22; see claim 1 step i and claim 12); (iii) comprises about 1011 colony forming units/g (CFU/g) dried bacterial culture (page 4, lines 29-30; see Fig. 2).
Regarding claim 12, pertaining to the method according to claim 2, Yde teaches wherein the method comprises freezing the concentrated bacterial culture to obtain a frozen bacterial culture (see claim 1 step h; see Example 2, line 26),
Claim 12 recites the property “wherein the frozen bacterial culture comprises about 104-1012 CFU/g frozen bacterial culture” (lines 3-4).
It is noted that properties of the obtained frozen bacterial culture, i.e. 104-1012 CFU/g frozen bacterial culture, implicitly result from performing the claimed method. Yde teaches the method of claim 12 and as such inherently teaches the recited property of the obtained frozen bacterial culture in claim 12.
Yde further teaches wherein the frozen bacterial culture comprises about 1011 CFU/g frozen bacterial culture (page 4, lines 29-30; see Fig. 2).
Regarding claim 16, please note the elected species of Lactococcus lactis under Election/Restrictions and the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the method according to claim 1, Yde teaches wherein the bacterial culture comprises Lactococcus lactis (page 6, line 2; page 11, line 5; see claim 8).
Regarding claim 17, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the method according to claim 1, Yde teaches the method further comprising adding a protective compound to the concentrated bacterial culture (page 7, lines 29-33; see Example 2 on page 12, lines 24-26).
Regarding claim 18, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the method according to claim 17, Yde teaches wherein the protective compound is a cryoprotectant (page 7, lines 29-33; see Example 2 on page 12, lines 24-26).
Claim 1-12 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (CN112126599A, published on 12/25/2020), hereinafter ‘Chen’, as evidenced by Gangurde et al. (“Whey protein”, published in 2011, Scholars' Research Journal, Vol. 1, Issue 2, pages 69-78), hereinafter ‘Gangurde’.
Chen’s general disclosure relates to a high-density culture method of Lactobacillus helveticus, and preparation and application of high-activity bacterial powder (see entire document, including abstract).
Regarding claim 1, pertaining to the method, Chen teaches a method of preparing a bacterial culture (see abstract) comprising: (a) culturing fermentative bacteria in a fermentation medium to obtain a bacterial culture (paragraphs [0018]-[0021]; see claim 4), wherein the fermentation medium has a pH of 4.5-5.5 at termination of the fermentation (paragraph [0020]-[0021]; see claim 6), and adjusting the pH to a pH from 6.0-7.0 after the fermentation (paragraphs [0023], [0060]; see claim 7 step a).
Regarding claim 2, pertaining to the method according to claim 1, Chen teaches the method further comprising concentrating the bacterial culture by a one-step concentration method to obtain a concentrated bacterial culture (paragraph [0024]; see claim 7 step b), and: freezing the concentrated bacterial culture to obtain a frozen bacterial culture (paragraph [0026]; see claim 7 step d); and removing water from the concentrated bacterial culture or the frozen bacterial culture to obtain a dried bacterial culture (paragraph [0026]; see claim 7 step d).
It is noted that the instant specification defines one-step concentration “as a concentration step that produces a concentrated bacterial culture in one step, and wherein the cells are maintained in suspension during the entire concentration step”, and further discloses that “[f]or the avoidance of doubt, a one-step concentration method does not include the two step method of (i) formation of a pellet of bacterial cells and (ii) resuspension of said cell pellet” (specification, page 7, lines 2-7). Chen is silent on resuspending after centrifugation of the fermentation broth and recites “a concentrated solution of Lactobacillus helveticus cells” (claim 7 step b). As such, Chen’s teachings read on the instant one-step concentration method.
Regarding claim 3, pertaining to the method according to claim 1, Chen teaches the method further comprising concentrating the bacterial culture by a one-step concentration method by centrifugal separation to obtain a concentrated bacterial culture (paragraph [0024]; see claim 7 step b).
Regarding claim 4, pertaining to the method according to claim 2, Chen further teaches wherein the method comprises the step of removing water (paragraph [0026]; see claim 7 step d), wherein the step of removing water is carried out by freeze drying (paragraph [0026]; see claim 7 step d).
Regarding claim 5, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the method according to claim 1, Chen teaches wherein the bacterial culture comprises fermentative bacteria selected from the genus Lactobacillus (paragraph [0012]).
Regarding claim 6, pertaining to the method according to claim 1, Chen teaches wherein the fermentation medium comprises (i) a carbohydrate (“whey powder”; paragraphs [0014], [0058]). It is noted that whey powder comprises the carbohydrate lactose, as evidenced by Gangurde et al. (see Table 5 on page 73).
Chen teaches wherein the fermentation medium comprises (ii) nitrogen sources (paragraphs [0014], [0058]).
Regarding claim 7, pertaining to the method according to claim 6, Chen teaches wherein the medium comprises a carbohydrate wherein (i) the carbohydrate is a disaccharide paragraphs [0014], [0058]). It is noted, as discussed above, that whey powder comprises the carbohydrate lactose, as evidenced by Gangurde (see Table 5 on page 73), and that lactose is a disaccharide.
Regarding claim 8, pertaining to the method according to claim 1, Chen teaches the method further comprising concentrating the bacterial culture by a one-step concentration method to obtain a concentrated bacterial culture (paragraph [0024]; see claim 7 step b), and adding a protective compound to the concentrated bacterial culture, wherein the protective compound is a lyoprotectant (paragraph [0025]; see claim 7 step c).
Regarding claim 9, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the method according to claim 1, Chen teaches wherein (i) said fermentation lasts 5-6 hours (paragraph [0019]); (ii) said fermentation is at a temperature of 37-43°C (paragraph [0018]; see claim 4 step 2).
Regarding claim 10, pertaining to the method according to claim 1, Chen teaches wherein adjusting the pH comprises adding the base ammonium hydroxide (paragraph [0060]).
Regarding claim 11, pertaining to the method according to claim 2, Chen teaches wherein the method comprises removing water from the concentrated bacterial culture or the frozen bacterial culture to obtain a dried bacterial culture (paragraph [0026]; see claim 7 step d).
Claim 11 recites properties of the obtained dried bacterial culture: (i) has a water activity (aW) of 0.01-0.8, (ii) is in form of a granulate or a powder, (iii) comprises 104-1013 colony forming units/g (CFU/g) dried bacterial culture, (iv) comprises a content of viable fermentative bacteria of 104-1013 CFU/g dried bacterial culture after storage for 16 weeks at 30°C and aw= 0.3, and (v) exhibits a loss of viability of less than 4 log units as measured by CFU/g after storage for 16 weeks at 30 °C and aw= 0.3 (lines 3-16).
It is noted that the properties of the obtained dried bacterial culture implicitly result from performing the claimed method. Chen teaches the method of claim 11 and as such inherently teaches the recited properties of the obtained dried bacterial culture in claim 11.
Chen teaches wherein the dried bacterial culture (ii) is in the form of a powder (paragraph [0026]; see claim 7 step d).
Regarding claim 12, pertaining to the method according to claim 2, Chen teaches wherein the method comprises freezing the concentrated bacterial culture to obtain a frozen bacterial culture (paragraph [0026]; see claim 7 step d).
Claim 12 recites the property “wherein the frozen bacterial culture comprises about 104-1012 CFU/g frozen bacterial culture” (lines 3-4).
It is noted that properties of the obtained frozen bacterial culture, i.e. 104-1012 CFU/g frozen bacterial culture, implicitly result from performing the claimed method. Chen teaches the method of claim 12 and as such inherently teaches the recited property of the obtained frozen bacterial culture in claim 12.
Regarding claim 17, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the method according to claim 1, Chen teaches the method further comprising adding a protective compound to the concentrated bacterial culture (paragraph [0025]; see claim 7 step c).
Regarding claim 18, please note the rejection under Claim Rejections - 35 USC § 112 (b) above.
Pertaining to the method according to claim 17, Chen teaches wherein the protective compound is a lyoprotectant (paragraph [0025]; see claim 7 step c).
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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 1, 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over (CN112126599A, published on 12/25/2020), hereinafter ‘Chen’, as evidenced by Gangurde et al. (“Whey protein”, published in 2011, Scholars' Research Journal, Vol. 1, Issue 2, pages 69-78), hereinafter ‘Gangurde’, in view of Berner et al. (“Effect of protective agents on the viability of Lactococcus lactis subjected to freeze-thawing and freeze-drying”, published in 2006, Scientia Pharmaceutica (Sci. Pharm.), Vol. 74, pages 137-149), hereinafter ‘Berner’.
Chen’s teachings have been set forth above.
Chen does not teach wherein the bacterial culture comprises or consists of one or more fermentative bacteria selected from bacteria of a genus selected from Lactococcus (instant claim 5), and wherein the bacterial culture comprises or consists of one or more fermentative bacteria selected from: Lactococcus lactis (instant claim 16). Please note the elected species “Lactococcus” and “Lactococcus lactis” under Election/Restrictions, and the rejection of claims 5 and 16 under the Claim Rejections - 35 USC § 112 (b) above.
Berner’s general disclosure relates to the effect of different protectants and the impact of the initial cell density on the viability of Lactococcus lactis Sr. 3.54 subjected to freeze-thawing and freeze-drying (see entire document, including abstract).
Regarding claim 5, pertaining to fermentative bacteria , Berner teaches a fermentative bacterium belonging to the bacterial genus Lactococcus (see abstract).
Regarding claim 16,pertaining to fermentative bacteria , Berner teaches a fermentative bacterium Lactococcus lactis (see abstract).
In addition, Berner teaches wherein “[l]actic acid bacteria and other biological materials used as starter cultures in the dairy industry or as silage preservants are often preserved by freezing and/or freeze-drying resulting in products with excellent long-term stability in most cases” (page 138, paragraph 1), and that “freeze-drying has some undesirable side effects, such as denaturation of sensitive proteins leading to decreased viability or activity” (page 138, paragraph 2).
While Chen does not teach wherein the bacterial culture comprises or consists of one or more fermentative bacteria selected from bacteria of a genus selected from Lactococcus (instant claim 5), and wherein the bacterial culture comprises or consists of one or more fermentative bacteria selected from: Lactococcus lactis (instant claim 16), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined Chen’s method with Berner’s Lactococcus lactis in order to create a method of preparing a bacterial culture wherein the bacterial culture comprises or consists of one or more fermentative bacteria selected from bacteria of a genus selected from Lactococcus, and wherein the bacterial culture comprises or consists of one or more fermentative bacteria selected from: Lactococcus lactis. One would have been motivated to do so to improve the viability and activity of freeze-dried Lactococcus or Lactococcus lactis (Berner, page 138, paragraphs 1-2). A skilled artisan would have reasonably expected success in combining Chen’s and Berner’s teachings since both are directed to preparing lactic acid bacteria cultures.
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, 5, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 11, and 17 of copending Application No. 17/297,936. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for similar methods for preparing a bacterial culture. ‘936 provides culturing fermentative bacteria in a fermentation medium, a pH of below 5.0 at termination of the fermentation, adjusting the pH to a pH of 6.5 after the fermentation, and wherein the fermentative bacteria are Lactobacillus, Lactococcus, and Lactococcus lactis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
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/SANDRA ZINGARELLI/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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