DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status and Formal Matters
The instant action is in response to papers filed 5/31/2026.
Claims 1 and 2 are identified as amended. It is noted claim 2 provides no markings required for amending claims. Thus claim 2 appears to be non-compliant with 37 CFR 1.121. However to promote compact prosecution and customer service the instant application will be examined. Future amendments not compliant with 37 CFR 1.121 may not be entered and examined.
The previous objection to the claims have been withdrawn in view of the amendment to the claims.
The independent claim has been amended to no longer require a microbial biofilm cellular mass. The clams now require a cellular mass of microbes, which has changed the scope of the claims. However the amendment has overcome the prior art of record.
The prior art rejection has been withdrawn in view of the amendment.
The ODP rejections have been withdrawn in view of the terminal disclaimer filed and approved 5/31/2026.
Priority
The instant application was filed 06/25/2025 and is a continuation of 18513577 , filed 11/19/2023, which is a continuation of 17457806 , filed 12/06/2021 , which is a continuation of 16699383 , filed 11/29/2019 ,which is a continuation of 16105017 , filed 08/20/2018 which is a Continuation of 15626971 , filed 06/19/2017 ,which is a continuation of 15484842 filed 04/11/2017 which is a Continuation of 15412712 , filed 01/23/2017 which is a Continuation of 15349371 , filed 11/11/2016 ,which is a Continuation of 15349420 , filed 11/11/2016 ,which is a continuation of 13503325 , filed 05/31/2012 ,which is a continuation of 13503325 which is a National Stage entry of PCT/US2011/059370 , International Filing Date: 11/04/2011 and claims priority from Provisional Application 61447735 , filed 03/01/2011.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 1 has been amended to recite “not alive” and “generally recognized as safe.” Review and searching of the specification did not reveal antecedent basis for these limitations.
Response to Arguments
This is a new ground of objection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163 IB New or amended claims section II
With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04
Claim 1 has been amended to recite, “cellular mass of microbes that have been grown in the biofilm phenotype, wherein said microbes are not alive.” The amendment has changed the scope of the invention from a microbial biofilm cellular mass of non-viable cells to a cellular mass of microbes grown in a biofilm phenotype. Thus the amendment has changed the scope. The response does not provide any indication of where support for the amendment can be found. Review and searching of the specification reveal “biofilm phenotype” 3 times on pages 2 and 3 of the specification in the background section. Thus the specification does not specifically envision “biofilm phenotype” as limitation of the invention. Further searching of the specification did not reveal antecedent basis for “not alive.” The amendment has provided no limitations which are not explicitly supported by the specification as originally filed and thus is new matter.
Further the claim 1 has been amended to recite “generally recognized as safe.” The response provides no indication of where support for the amendment is found. Review and searching of the specification found the previous “generally regarded as safe” thus the amendment appears to change the scope of the invention from what was previously changed and is not supported by the specification. Thus the amendment appears to be new matter.
Response to Arguments
This is a new ground of rejection necessitated by amendment.
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 1-2 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 1 has been amended to recite, “the biofilm phenotype.” The metes and bounds are unclear as the claim does not previous recite, “biofilm phenotype.” Further the recitation suggests there is a non-biofilm phenotype. The specification and claims provide no limiting definition of how to differentiate a biofilm phenotype from a non-biofilm phenotype. Thus the metes and bounds are unclear.
Further claim 1 recites, “edible ingredients that are generally recognized as safe (GRAS).” This suggests there are edible ingredients that are generally recognized as non-safe. The specification recites, “GRAS” twice. The specification provides no standard to differentiate generally recognized as safe from generally regarded not safe Thus the metes and bounds are unclear.
Claim 2 recites “the biofilm cellular mass.” The metes and bounds are unclear as claim 1 no longer provides antecedent basis for this limitation. This rejection can be overcome by amendment to provide antecedent basis for the limitation in the claim.
Response to Arguments
The response traverses the rejection providing arguments with respect to FDA title 21 and 12 patents. The response asserts one of skill in the art would recognize what is required when the claim is read in the light of the specification. The response does not provide title 21 of FDA or an of the cited patents or provide any art accepted definition. Thus the response appears to merely provide arguments of counsel. As stated in the MPEP, 2145 “Arguments of Counsel”
“If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc). Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984)..”
This should not be construed as an invitation for providing evidence. As further stated in the MPEP 716.01 regarding the timely submission of evidence:
A) Timeliness.
Evidence traversing rejections must be timely or seasonably filed to be entered and entitled to consideration. In re Rothermel, 276 F.2d 393, 125 USPQ 328 (CCPA 1960). Affidavits and declarations submitted under 37 CFR 1.132 and other evidence traversing rejections are considered timely if submitted:
(1) prior to a final rejection,
(2) before appeal in an application not having a final rejection, or
(3) after final rejection and submitted
(i) with a first reply after final rejection for the purpose of overcoming a new ground of rejection or requirement made in the final rejection, or
(ii) with a satisfactory showing under 37 CFR 1.116(b) or 37
CFR 1.195, or
(iii) under 37 CFR 1.129(a).
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kailaspathy (LWT 41 (2008) 1317–1322) as evidenced by Gudina et al (Letters in
Applied Microbiology Vol. 50, pp 419-424, 2010).
While claim 1 has been amended to recite, “cellular mass of microbes that have been grown in the biofilm phenotype.” This appears to be a limitation making it a product by process. However, MPEP 2113 states:
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Kailaspathy teaches, “During storage the average viable cell counts of L. acidophilus LAFTIs L10 decreased from 7.81 107cfu/g on day 0 to 4.54 107cfu/g on day 35 whereas that of B. animalis ssp.”
Gudina et al set forth that Lactobacillus inherently secretes a biosurfactant. (See abstract).
Thus Doyle teaches yogurt which is generally recognized as safe with a dead L. acidophilus at day 35.
Claim 2 is rejected as it is unclear what is required in view of the 112 issues.
Summary
No claims are allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ouwehand (Int. Dairy Journal 8 (1998) 749—758)
Lacriox (Current Opinion in Biotechnology 2007, 18:176–183)
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 STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Steven Pohnert/Primary Examiner, Art Unit 1683
Prosecution Insights