DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 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.
Benefit of Earlier Filing Date
The instant application was filed 21 September 2023; a CON of U.S. Pat. App. Serial No. 17/832,040, filed 3 June 2022 (now U.S. Pat. No. 11,779,559); a CON of U.S. Pat. App. Serial No. 16/620,124, filed 6 December 2019 (now U.S. Pat. No. 11,382,885); a national stage application of PCT/US2018/036501, filed 7 June 2018; and claims the benefit of U.S. Prov. Pat. App. Serial No. 63/516,587, filed 7 June 2017. Applicant’s claim is acknowledged.
Status of the Claims
The listing of claims filed 29 November 2023 has been examined.
Claims 21–40 are pending and new. Claims 1–20 are canceled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 28 March 2024 is acknowledged and has been considered.
Objections to the Abstract
The abstract of the disclosure is objected to because it recites phrases that can be implied (“The disclosure provides”) and legal phraseology (“comprising”).
Appropriate correction is required.
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Objections to the Specification
The specification is objected to because it contains one or more typographical errors.
The term “Stomatoccus mucilaginosu” in Table A (Spec., p.4, ¶13) appears to be a misspelled version of Stomatococcus mucilaginosus.
Appropriate correction is required.
Claim Objections
Claim 36 is objected to for containing one or more typographical errors.
Claim 36 recites, “Stomatoccus mucilaginosus,” which appears to be a misspelled version of Stomatococcus mucilaginosus.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21–30 and 32–35 are rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by US 2015/0126571 (“Bryan”) [IDS] as evidenced by Aminosyn 10% label.
Bryan discloses a method of treating a bacterial infection, including a Staphylococcus aureus infection and methicillin resistant varieties thereof, comprising administering a composition comprising Aminosyn 10% and L-cysteine. (Bryan, ¶¶7, 13). Aminosyn 10% contains aspartic acid and glutamic acid. (Id., ¶13). The L-cysteine was added to the solution of Aminosyn 10% for testing. (Id.). Thus, Bryan discloses a method of administering a composition comprising aspartic acid, glutamic acid, and L-cysteine to treat a methicillin resistant Staphylococcus aureus infection.
Bryan discloses oral, intravenous, and topical administrations, as well as nasal irrigation. (Id., ¶¶10,22–24; claims 3, 4, 7, 9, 12, 14).
Regarding the concentrations in claims 23, 24, 32, and 33, Aminosyn 10% label discloses 700 mg of L-aspartic acid and 738 mg of L-glutamic acid per 100 mL.
Claim Rejections - 35 U.S.C. § 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.
The factual inquiries 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 nonobviousness.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
(i) Claims 31 and 36–39 are rejected under 35 U.S.C. § 103 as being unpatentable over Bryan as evidenced by Aminosyn 10% label in view of WO 2015/038339 (“Hancock”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
The discussions of Bryan as evidenced by Aminosyn 10% label in the rejection above are incorporated herein by reference.
Hancock discloses peptide compositions for inhibiting the growth of biofilms. (Hancock, ¶¶1, 118). Hancock discloses a method of administering the composition for inhibiting the growth of a microbe. (Id., ¶17). Hancock states the microbe can be Staphylococcus aureus, Staphylococcus epidermidis, and Enterococcus faecalis, and that each are Gram-positive bacterium. (Id., ¶17, “the microbe can be a Gram positive bacterium, such as Staphylococcus aureus, Staphylococcus epidermidis, or Enterococcus faecalis.”); (Id., claim 11, “wherein the bacteria is Staphylococcus aureus, Staphylococcus epidermidis, or Enterococcus faecalis.”).
Ascertaining the differences between the prior art and the claims at issue
Bryan does not disclose a method of treating a Staphylococcus epidermidis, Enterococcus faecalis, Rothia dentocariosa, Streptococcus, or Stomatoccus mucilaginosus infection.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include data related to treating an Enterococcus faecalis infection, a Rothia dentocariosa infection, a Streptococcus infection, or a Stomatoccus mucilaginosus infection. Example 5, which mentions one or more of the bacteria, is prophetic and does not refer to data.
The question of obviousness
Based on the above factors, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Bryan and Hancock because the references are in a related field directed to the treatment of bacterial infections, including drug resistant bacteria. Because the claimed method is generally disclosed in Bryan for the treatment of Staphylococcus aureus, and Hancock discloses Staphylococcus aureus, Staphylococcus epidermidis, and Enterococcus faecalis are each a Gram positive bacterium that can be treated with the same composition, as evidenced by their grouping together in the specification and claim, a person having ordinary skill in the art prior to the filing of the instant application would have been a reasonable expectation of success in applying the method disclosed in Bryan to the other common Gram positive bacterium (Staphylococcus epidermidis and Enterococcus faecalis) in Hancock.
One of ordinary skill in the art would have been motivated to combine the teachings of the cited references to provide an additional treatment for drug resistant bacteria. There would have been a reasonable expectation of success at arriving at the claimed invention because the method is generally known in Bryan and the modification is directed to a common type of bacterial infection.
(ii) Claims 36 and 40 are rejected under 35 U.S.C. § 103 as being unpatentable over WO 98/56411 (“Hillman”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Hillman discloses SEQ ID NO.:2, which is a composition comprising aspartic acid, cysteine, and glutamic acid. (Hillman, 18:39–19:11) (page:line).
Hillman states: “Sequence ID NO: 2 is the pre-protein form which, after proteolytic cleavage and other processing by other factors present in the host organism, results in the synthesis of mutacin 1140 as shown in Figure 3.” (Id., 6:18–20).
Hillman discloses the administration of a composition of mutacin 1140 to Streptococcus mitis and Streptococcus salivarius and the strains exhibited sensitivity to the composition.
Ascertaining the differences between the prior art and the claims at issue
Hillman does not disclose a method of administering to a subject in need thereof a composition comprising Sequence ID NO: 2 to treat a Streptococcus mitis or Streptococcus salivarius infection.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill is discussed in the rejection above and that discussion is incorporated by reference for the purpose of this rejection.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include data related to treating a Streptococcus infection.
The question of obviousness
Based on the above factors, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed method of treating a Streptococcus infection by administering a composition comprising aspartic acid, cysteine, and glutamic acid because Hillman discloses such a composition that can convert in vivo to mutacin 1140 and Streptococcus mitis and Streptococcus salivarius strains are sensitive to mutacin 1140.
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 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); In re Longi, 759 F.2d 887 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937 (CCPA 1982); In re Vogel, 422 F.2d 438 (CCPA 1970); In re Thorington, 418 F.2d 528 (CCPA 1969).
Please note the following information regarding terminal disclaimers:
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(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.
(i) Claims 21–40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9–13 of U.S. Pat. No. 11,779,559 (reference claims).
18/371,085
11,779,559
21. A method of treating or preventing a methicillian-resistant Staphylococcus aureus infection . . .
9. A method of disrupting an existing biofilm on a surface, preventing formation of a biofilm on a surface, or a combination thereof . . .
The term “surface” in the reference claim is not limited to any particular surface. Thus, the term “surface” in the reference claims encompasses a surface outside of the human body as well as an internal mucosal surface, such as the gastrointestinal tract, as discussed in the Specification. (Spec., ¶¶4–6; US 11,779,559 at 1:36–2:27) (col:lines). Staphylococcus aureus, including methicillian-resistant, can develop into a biofilm. (Id.).
Although the claims at issue are not identical, they are not patentably distinct from one other because they cover a method of treating or preventing a Staphylococcus aureus infection (that can form a biofilm on a surface) with the same composition. Accordingly, an infringer of a patent granted based on the claims of the instant application or the reference claims would also be an infringer of the other.
(iii) Claims 21–40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 14 of U.S. Pat. No. 11,382,885 (reference claims).
18/371,085
11,382,885
21. A method of treating or preventing a methicillian-resistant Staphylococcus aureus infection . . .
6. A method of preventing formation of biofilm, disrupting an existing biofilm on a surface, or a combination thereof . . .
14. A method of preventing formation of biofilm, disrupting an existing biofilm on a surface, or a combination thereof . . .
The term “surface” in the reference claim is not limited to any particular surface. Thus, the term “surface” in the reference claims encompasses a surface outside of the human body as well as an internal mucosal surface, such as the gastrointestinal tract, as discussed in the Specification. (Spec., ¶¶4–6 ; US 11,382,885 at 1:36–2:25). Staphylococcus aureus, including methicillian-resistant, can develop into a biofilm. (Id.).
Although the claims at issue are not identical, they are not patentably distinct from one other because they cover a method of treating or preventing a Staphylococcus aureus infection (that can form a biofilm on a surface) with the same composition. Accordingly, an infringer of a patent granted based on the claims of the instant application or the reference claims would also be an infringer of the other.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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 submit an Automated Interview Request: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
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.
/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623