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 .
The response filed 4-20-2026 has been entered into the claims.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I (no or a mutant pepR) in the reply filed on 4-20-2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements have been considered. Initialed copies are enclosed.
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 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.
Claims 1-12 and 14 (all in part) are rejected under 35 U.S.C. 112(a), 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. While all of the factors have been considered, only those required for a prima facie case are set forth below.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
Partial structure/correlation between structure and function
The claims are drawn to a Paenibacillus sp. strain comprising no or a mutant PepR wherein the missing PepR or the mutant PepR results in a decreased viscosity of a liquid culture of the Paenibacillus sp. strain in comparison to a liquid culture of a Paenibacillus sp strain comprising wildtype PepR. The viscosity in liquid culture is a result of the production of polysaccharides, exopolysaccharides in particular (see paragraph bridging pages 1-2 of the specification). The claims encompass any and all Paenibacillus species and strains thereof (see for example claim 6) and any and all mutations of pepR that provide for the recited functional effect. The specification teaches a single knockout of pepR in Paenibacillus polymyxa strain LU17007 (see Table 2). The specification teaches that this knockout strain has decreased viscosity in a liquid culture as compared to the wild-type LU17007 strain from which it was derived only and does not compare to any other species or strains containing a wild-type pepR gene (claims 6 and 7). The art teaches that deletion of pepR in other strains of Paenibacillus polymyxa does not provide for reduced exopolysaccharide production which would lead to reduced viscosity in liquid culture (see He et al, Microorganisms 2021, page 6, section 3.3 and page 8 section 3.4; of record in PTOL-1449). The specification does not teach any functional effect of any single point mutations in the pepR gene with respect to the claimed W224* or S393F mutations in strain LUL17007 or any other Paenibacillus species or strains. The effect of any specific mutation or mutations in pepR gene leading to mutations in the PepR protein at conserved positions within Figure 2 is unknown. The correlation of specific mutations within the gene/protein structure with the claimed function is not set forth in the specification as filed. The art does not provide such a correlation. Furthermore, the art teaches that exopolysaccharide production by fermentation in Paenibacillus spp is highly variant and depends on the fermentation conditions, medium composition, temperature, pH and culture vessel (see Liang et al, page 1851, Table 1; of record). Moreover, different species produce different exopolysaccharides with presumably different genes and different mechanism of production (see Liang et a, page 1858, section 5.4; of record). The combined effect of unknown and undisclosed mutations with other mutations in other genes/proteins listed has not been demonstrated. Ruterig (Dissertation 2019; of record) teach that although numerous exopolysaccharide operons and pathways have been known for decades, several details on molecular and regulatory mechanisms of EPS biosynthesis are still unknown and if or to what extend a gene contributes to EPS biosynthesis can varia from strain to strain. Ruterig also teaches that the annotation of genes is often ambiguous and putative substrates or acceptors can only be hypothesized until experimentally proven (see page 21, last paragraph in section 1.2.3). The courts have held that a sufficient number of representative species must be included “to demonstrate that the patentee possessed the full scope of the [claimed] invention.” Lizardtech, Inc. v. Earth Resource Mapping, Inc. 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005).
Physical and chemical properties
Weighing all the factors, the breadth of the claims, the lack of correlation between structure and function of the extracts, level of knowledge and skill in the art, one of ordinary skill in the art would not recognize from the disclosure that the applicant was in possession of the full genus of Paenibacillus sp strains having a knockout (“no” pepR) or mutants of PepR which would have the functional properties in liquid culture as set forth in the claims. At best, it simply indicates that one should run tests on a wide spectrum of deletions and mutants in different strains and different species of Paenibacillus in the hope that at least one of them will work. Finally, the courts have held that the disclosure is insufficient when testing is necessary to determine the actual use or possible lack of use (In re Kirk and Petrow 153 USPQ 48 (CCPA 1967). Therefore, the written description requirement is prima facie not satisfied.
Claims 1-12 and 14 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, or for pre-AIA the applicant regards as the invention.
As to claim 1 and every claim dependent thereon, the claims are unclear in the basis for comparison, is the Paenibacillus sp. strain having the wildtype PepR is the strain from which the mutation is derived ? The claim appears to compare the knockout or mutant to any species or strain with a wild-type gene. Clarification is requested.
As to claim 2, the claim is indefinite in the recitation of Figure 2 and conserved sequences as the claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). Here, the conserved sequence can be represented by a separate sequence in the sequence listing.
As to claim 12, the claim recites the acronym “EPS”, while acronyms are permitted in the claims, for clarity, the acronym must first be preceded by the full text of what the acronym represents. Correction is required.
Free of the Prior Art
The claims reciting a Paenibacillus sp. strain comprising no or a mutant of pepR are free of the prior art. The closest prior art is He et al, (Microorganism, 9:289, 2021) which teaches that deletion of the pep-1 gene cluster comprising pepR gene (i.e. no pepR) does not result in a decreased or reduced quantity of exopolysaccharides as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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, Jeffrey Stucker can be reached at 571-272-0911. 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.
/Patricia Duffy/Primary Examiner, Art Unit 1645
Prosecution Insights