The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I and Corynebacterium accolens in the reply filed on 2-5-2026 is acknowledged. Claims 12-24 are pending. Claims 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 12-21 are currently under examination.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). See page 25 for example.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pages 9-10 and 25 for example). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
It should be noted that the cited occurrences of improper use are only exemplary and Applicant should review the entire specification to correct any other improper use of embedded hyperlink and/or other form of browser-executable code.
Information Disclosure Statement
To date no Information Disclosure Statement has been filed in this application.
It should be noted that 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.
Claim Objections
Claims 12-18 and 20-21 are objected to for reciting claim language drawn to non-elected inventions
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.
Biological Deposit
Claims 16 and 18-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that the Corynebacterium accolens strain SU001 and Corynebacterium propinquum strain SU002 and SU003 represented by the NCAIM accession numbers NCAIM (P) 001495, NCAIM (P) 001496 and NCAIM (P) 001497 (respectively) are required in order to practice the invention. The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of organisms under the NCAIM accession numbers NCAIM (P) 001495, NCAIM (P) 001496 and NCAIM (P) 001497 in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
Written Description
Claims 12-21 are 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.
The instant claims are drawn to methods of preventing an infection by and all coronaviruses by the administration of a Corynebacterium culture wherein said culture is capable of reducing expression of either an angiotensin-converting enzyme 2 (ACE2) or and transmembrane protease/serine subfamily member 2 (TMPRSS2). Dependent claims require that the claimed Corynebacterium culture:
inhibit binding between the Spike (S) protein of the coronavirus, preferably the binding between the receptor binding domain (RBD) of the S protein and ACE2 (claim 13);
inhibiting the growth of Streptococcus bacteria, preferably at least one of Streptococcus mitis and Streptococcus sanguis (claim 14);
comprise at least one of Corynebacterium accolens SU001 strain having the accession number NCAIM (P) B 001495, or a derivative, variant or mutant thereof, wherein the derivative, variant or mutant thereof is capable of reducing ACE2 expression and/or TMPRSS2 expression and/or inhibiting ACE2 and S-protein binding, and/or inhibiting the growth of Streptococcus bacteria and/or is able to grow in presence of Streptococcus bacteria and/or is expressing LipS 1 lipase; Corynebacterium propinquum SU002 strain having the accession number NCAIM (P) B 001496, or a derivative, variant or mutant thereof, wherein the derivative, variant or mutant thereof is capable of reducing ACE2 expression and/or TMPRSS2 expression and/or inhibiting ACE2 and S-protein binding and/or is able to grow in the presence of Streptococcus bacteria; Corynebacterium propinquum SU003 strain having the accession number NCAIM (P) B 001497, or a derivative, variant or mutant thereof, wherein the derivative, variant or mutant thereof is capable of reducing ACE2 expression and/or TMPRSS2 expression and/or inhibiting ACE2 and S-protein binding and/or is able to grow in the presence of Streptococcus bacteria (claim 16);
is effective in preventing SARS coronavirus infection (claims 17);
comprises a Corynebacterium accolens SU001 strain having the accession number NCAIM (P) B 001495, or a derivative, variant or mutant thereof, wherein the derivative, variant or mutant thereof is capable of reducing ACE2 expression and/or TMPRSS2 expression and/or inhibiting ACE2 and S-protein binding, and/or inhibiting the growth of Streptococcus bacteria and/or is able to grow in presence of Streptococcus bacteria and/or is expressing LipS 1 lipase (claim 18).
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of coronavirus vaccines comprising a Corynebacterium culture with the claimed immunological and phenotypic characteristics, Applicant must adequately describe the specific species (and genotype/phenotype thereof) of Corynebacterium that has efficacy in preventing an infection by a given coronavirus as well as culture conditions, dosages and means of administration.
However, the specification does not disclose distinguishing and identifying features of a representative number of members of the genus of strains of Corynebacterium to which the claims are drawn, such as a correlation between the structure of the bacteria (i.e. genome and phenotype) and its recited function (i.e. prevent the growth of any and all coronavirus infections) so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of cleaning compositions. Moreover, the specification fails to disclose what genotype/phenotype must be possessed by a given Corynebacterium strain to have efficacy in preventing the growth of a given coronavirus species. The specification is limited to in vitro studies looking at the interaction of ACE2-spike binding activity, the effect of Corynebacterium strains of the growth of Streptococcus mitis or Streptococcus sanguis; or the effect of Corynebacterium strains of the expression of the ACE2 receptor on human cells. This limited disclosure cannot be extrapolated to the full scope of the compositions encompassed by the rejected claims. Therefore, since the specification fails to adequately describe at least a substantial number of members of the genus Corynebacterium strains to which the claims refer it fails to properly describe the genus of coronavirus vaccines. The term “vaccinate” is defined as the use of a specific antigen to induce protective immunity to infection or disease induction. The specification does not provide substantive evidence that the claimed vaccines are capable of inducing protective immunity. This demonstration is required for the skilled artisan to be able to use the claimed vaccines for their intended purpose of preventing infections. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the administration of the claimed vaccines, i.e. would not be able to accurately predict if protective immunity has been induced. The ability to reasonably predict the capacity of a single bacterial immunogen to induce protective immunity from in vitro studies is problematic. Ellis (Vaccines, W.B. Saunders Company, Chapter 29, 1988, pages 568-574) exemplifies this problem in the recitation that "the key to the problem (of vaccine development) is the identification of the protein component of a virus or microbial pathogen that itself can elicit the production of protective antibodies"(page 572, second full paragraph). Unfortunately, the art is replete with instances where even well characterized antigens that induce an in vitro neutralizing antibody response fail to elicit in vivo protective immunity. See Boslego et al (Vaccines and Immunotherapy, 1991, Chapter 17), wherein a single gonococcal pillin protein fails to elicit protective immunity even though a high level of serum antibody response is induced (page 212, bottom of column 2). Accordingly, the art indicates that it would require empirical testing to formulate and use a successful vaccine without the prior demonstration of vaccine efficacy.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the 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 Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Moreover, the describing of a biological entity by their functions was addressed in the Centocor decision (CENTOCOR ORTHO BIOTECH, INC. v ABBOTT LABORATORIES (Fed Cir, 2010-1144, 2/23/2011)). In said case the court stated”
To satisfy the written description requirement, "the 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,' and demonstrate that by disclosure in the specification of the patent." Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991)). Assessing such "possession as shown in the disclosure" requires "an objective inquiry into the four corners of the specification." Ariad, 598 F.3d at 1351. Ultimately, "the specification must describe an invention understandable to [a person of ordinary skill in the art] and show that the inventor actually invented the invention claimed." Id. A "mere wish or plan" for obtaining the claimed invention is not adequate written description. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997).
The court further opined that Centocor's suggestion
that our decision in Noelle and the PTO written description guidelines support the view that fully disclosing the human TNF-α protein provides adequate written description for any antibody that binds to human TNF-α. That suggestion is based on an unduly broad characterization of the guidelines and our precedent.
The court concluded that
While our precedent suggests that written description for certain antibody claims can be satisfied by disclosing a well-characterized antigen, that reasoning applies to disclosure of newly characterized antigens where creation of the claimed antibodies is routine. Claiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described.
Therefore, because the art is unpredictable, in accordance with the MPEP and currently caselaw, the description of claimed Corynebacterium cultures is not deemed representative of the genus of coronavirus vaccines to which the claims refer.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 May 29, 2026
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