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 with traverse of the invention of Group II, a bacteriophage lysin chimera, in the reply filed on 04/06/2026 is acknowledged. The traversal is on the ground(s) that the claims do not lack unity of invention in light of the extensive amendments of 04/06/2026. This argument is found persuasive with respect to new claims 44-77. This argument is not found persuasive with respect to new claims 78-81 because these claims recite a method of using the chimera of claim 16 “or a single binding domain thereof, or a series combination of similar or different binding domains thereof,” which is significantly broader than the chimera of claim 16. As such, claim 78 and its dependents lack unity of invention with claim 16 because they represent methods of using proteins other than the protein of claim 16.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 04/06/2026 has been entered. Claims 16-17 and 39-82 are pending in this US patent application. Claims 78-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/06/2026.
Claims 16-17, 39-77, and 82 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 03/22/2024 has been received and considered.
Specification
The disclosure is objected to because of the following informalities:
The title of the application recites “lysine” instead of “lysin”.
Appropriate correction is required.
Claim Objections
Claims 49, 57, and 77 are objected to because of the following informalities:
Claims 49 and 77 do not end in a period.
Claim 57 recites a “nucleotide acid sequence,” which should read either “nucleotide sequence” or “nucleic acid sequence”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 44, 61, 63-64, 67, 70-71, 75-77, and 82 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.
The terms “full” and “half” in claim 44 are relative terms that render the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What constitutes a “full” linker or a “half” linker? As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claim 44, rendering it indefinite.
Claim 61 recites the limitation "the preparation of drugs, cosmetics, or medical devices" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 63 recites the limitation "the device-related infection" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 64 recites the limitation "the infection" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 64 depends from claim 62, which recites multiple types of infection, and so it is unclear which of the infection types in claim 62 is to be limited by “the infection” in claim 64.
Regarding claim 67, the phrase "or other similar device" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "or other similar device"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Claim 70 recites a method for preparing a bacteriophage lysin chimera. Step 1 of the method recites, in its entirety, “synthetic domain sequences and primers for amplifying domain sequences,” which is a list of compositions and not a method step. As such, one of ordinary skill in the art would be unable to determine the metes and bounds of step 1 of the method of claim 70, rendering the claim indefinite.
Claim 71 includes a period in the middle of the claim (line 6). It is unclear whether the material following the period is intended to be part of the claimed method, rendering the claim indefinite.
Claims 75-77 recite the chimera of claim 16 “in the application of claim 16 is used for” various purposes. It is unclear whether these claims are intended to recite compositions or methods.
Claim 82 recites the limitation "the method" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Therefore, claims 44, 61, 63-64, 67, 70-71, 75-77, and 82 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted the linkers of claim 44 to be any linker that falls within the scope of claim 40. The Examiner has interpreted “the preparation” in claim 61 as “a preparation.” The Examiner has interpreted claim 63 to recite “the instrument-related infection” instead of “the device-related infection.” The Examiner has interpreted claim 64 as depending from claim 61 instead of claim 62. The Examiner has interpreted claim 67 without the phrase “or other similar device.” The Examiner has interpreted step 1 of claim 70 as “adding synthetic domain sequences and primers for amplifying domain sequences to a reaction mixture.” The Examiner has interpreted the period in the middle of claim 71 as a semicolon. The Examiner has interpreted claims 75-77 as methods of using the chimera of claim 16. The Examiner has interpreted claim 82 as a method for the treatment of P. acnes infection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 73-74 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 73 depends from claim 16 and recites that the chimera may have a particular level of sequence similarity to “an alternative amino acid sequence with the same functional group,” which is considerably broader than the bacteriophage lysin chimera of claim 16. Claim 74 depends from claim 73, thereby also incorporating its significantly broadened scope. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
Claim 16 is allowable. The closest prior art to claim 16 is found in the teachings of Marinelli, as discussed in the previous Office action. However, Marinelli does not teach or suggest the particular bacteriophage lysin chimera recited in amended claim 16. As such, claim 16 and claims that incorporate all of its limitations are free of the prior art.
As discussed above, claim 78 and its dependents are not currently eligible for rejoinder with allowable claim 16 because claim 78 does not require all of the limitations of claim 16. However, in the interest of compact prosecution, the Examiner offers the following comments on the language of claims 78-81 for Applicant’s review if they wish to amend claim 78 to require all of the limitations of claim 16:
Claim 78 recites a method in which the only method step is “using.” Claim 80 depends from claim 78 and recites ways in which the fusion is “used.” It is unclear what action “using” or “used” is intended to be, and so one of ordinary skill in the art would be unable to determine the metes and bounds of the claimed methods.
Claim 79 recites that the fusion of the chimera/binding domain and signaling molecules “are joined by” gene fusion or chemical coupling. It is unclear whether “are joined by” indicates that the fusion of the chimera/binding domain and the signaling molecules is accomplished via gene fusion or chemical coupling or whether “are joined by” indicates that gene fusion or chemical coupling occurs in addition to the fusion of the chimera/binding domain and the signaling molecules.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 81 recites the broad recitations “fluorescent dyes,” “protein tags,” and “enzymes,” and the claim also recites that these substances “include” various species, which are the narrower statements of the ranges/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 44, 61, 63-64, 67, 70-71, 73-77, and 82 are rejected. Claims 49, 57, and 77 are objected to. Claims 16-17, 39-43, 45-48, 50-56, 58-60, 62, 65-66, 68-69, and 72 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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 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, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 06/09/2026
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