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 .
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.
Current Status of 18/691,806
This Office Action is responsive to the amended claims received 9 October 2024.
Claims 1-7, 10, 12, 14, 17-21, 23-24, 28, and 31-32 are currently pending.
Priority
Applicant’s claim for the benefit of the prior-filed patent applications PCT/US2022/076556 (filed 16 September 2022) and 63/244,779 (filed 16 September 2021) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
The Examiner has determined, for the purposes of the instant action, that the effective filing date of the instant claims is 16 September 2021, because sufficient support was not found in earlier-filed documents.
Information Disclosure Statement
The information disclosure statement (IDS) received on 15 July 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this information disclosure statement is being considered by the examiner.
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.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequences begin on page 39 of the instant specification.
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.
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pages 45 and 62-63. 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(VII).
Claim Objections
Claim 24 is objected to because of the following informalities: Claim 24 appears to contain the words “of limonene” written as “oflimonene”. Appropriate correction is required.
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, 3-7, 10, 12, 14, 17, and 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 claims contain 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.
Factors to be considered in making this determination include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number for a prima facie case are discussed below.
Claims 1, 3, 17, and 19 recite embodiments that inhibit one or more glomeruli of a mosquito. However, the instant claims and specification do not describe what compounds, or even which classes of compounds, act to inhibit mosquito glomeruli. Therefore, working examples are not given by the instant application to support the claims listed above. This also represents an insufficient amount of direction provided by the inventor. For these reasons, claims 1, 3-7, 10, 12, 14, 17, and 19 are found to lack enablement. Claims 2 and 18 are not found to lack enablement, because they are specifically directed to embodiments that activate the glomeruli of mosquitos.
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 20-21, 23-24, 28, and 31-32 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.
Claim 20 recites “wherein the formulation mimics the neural activity evoked by human odor in the mosquito brain”. It is not clear how a formulation could mimic neural activity. This renders claims 20-21, 23-24, 28, and 31-32 indefinite. Applicant may choose to amend the quoted phrase above to read “wherein the formulation causes neural activity
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4-7, 17-18, 20-21, 23-24, 28, and 32 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a natural phenomenon, including products of nature, without significantly more. The instant claims recite a composition for attracting mosquitos made up of a compound capable of activating both recited glomeruli of a mosquito, and this composition may be made up of decanal, 1-hexanol, and geranyl acetone. MEIJERINK (Cited by Applicant in IDS of 15 July 2024; Meijerink, J.; Braks, M.A.H.; et al. “IDENTIFICATION OF OLFACTORY STIMULANTS FOR Anopheles gambiae FROM HUMAN SWEAT SAMPLES” Journal of Chemical Ecology, Vol. 26, No. 6, 2000) teaches the chemical makeup of fresh human sweat and sweat that has been held at 37 degrees C for 42-52 hrs. (referred to as “incubated” sweat samples therein), and the response of Anopheles gambiae mosquitos to that sweat (abstract, materials and methods section, Table 2). It is reasonable that: any human that has not washed for 42 hours would naturally bear the same composition present in the “incubated” sweat samples of MEIJERINK on their skin. MEIJERINK teaches that female Anopheles gambiae mosquitos were attracted to the sweat that was held at 37 degrees C for 42-52 hrs. Table 2 of MEIJERINK teaches the compounds that were found to be present in the incubated sweat, including decanal (present at 0.6 % of total peak area), 1-hexanol (present at 0.7 % of total peak area), and geranyl acetone (present at 6.0 % of total peak area).
MEIJERINK provides evidence that human sweat, being a natural product, on humans that have not washed in 42 hours falls meets all of the required limitations of the instant claims rejected in this section.
Regarding claims 17 and 32: The introduction section of MEIJERINK discusses the natural process of Anopheles gambiae mosquitos searching for humans, detecting a human via organic compounds in sweat, and drinking their blood.
Regarding claim 23: MEIJERINK teaches that nicotine is present in the incubated human sweat (0.9 % of total peak area). The instant specification provides no closed definition for “toxicants”. Therefore, the Examiner has determined that nicotine reasonably falls within the scope of “toxicants”.
This judicial exception is not integrated into a practical application, because the claims above provide no limitations beyond that which occurs naturally. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because the claims above provide no claim limitations beyond that which occurs naturally. For example, claim 31 is not rejected under this section, because it requires a trapping chamber, which is not found in nature.
Claim Rejections - 35 USC § 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 1-2, 4-7, 17-18, 20-21, 23-24, 28, and 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
MEIJERINK (Cited by Applicant in IDS of 15 July 2024; Meijerink, J.; Braks, M.A.H.; et al. “IDENTIFICATION OF OLFACTORY STIMULANTS FOR Anopheles gambiae FROM HUMAN SWEAT SAMPLES” Journal of Chemical Ecology, Vol. 26, No. 6, 2000).
MEIJERINK teaches the chemical makeup of fresh human sweat and sweat that has been held at 37 degrees C for 42-52 hrs. (referred to as “incubated” sweat samples therein), and the response of Anopheles gambiae mosquitos to that sweat (abstract, materials and methods section, Table 2). It is reasonable that: any human that has not washed for 42 hours would naturally bear the same composition present in the “incubated” sweat samples of MEIJERINK on their skin. MEIJERINK teaches that female Anopheles gambiae mosquitos were attracted to the sweat that was held at 37 degrees C for 42-52 hrs. Table 2 of MEIJERINK teaches the compounds that were found to be present in the incubated sweat, including decanal (present at 0.6 % of total peak area), 1-hexanol (present at 0.7 % of total peak area), and geranyl acetone (present at 6.0 % of total peak area).
Regarding claims 17 and 32: The introduction section of MEIJERINK discusses the natural process of Anopheles gambiae mosquitos searching for humans, detecting a human via organic compounds in sweat, and drinking their blood.
Regarding claim 23: MEIJERINK teaches that nicotine is present in the incubated human sweat (0.9 % of total peak area). The instant specification provides no closed definition for “toxicants”. Therefore, the Examiner has determined that nicotine reasonably falls within the scope of “toxicants”.
Regarding claim 31: The behavioral assay section of page 1370 of MEIJERINK teaches that sweat samples were placed within a Perspex trapping device for mosquitos.
Claim Rejections - 35 USC § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-7, 10, 12, 14, 17-18, 20-21, 23-24, 28, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over:
MEIJERINK (Cited by Applicant in IDS of 15 July 2024; Meijerink, J.; Braks, M.A.H.; et al. “IDENTIFICATION OF OLFACTORY STIMULANTS FOR Anopheles gambiae FROM HUMAN SWEAT SAMPLES” Journal of Chemical Ecology, Vol. 26, No. 6, 2000).
Teachings of MEIJERINK are discussed above. Table 1 of MEIJERINK teaches that incubated sweat samples caused far more mosquitos to be caught in traps compared to fresh sweat samples.
Regarding claims 10, 12, and 14: It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to dilute the incubated sweat composition taught by MEIJERINK for the purpose of determining if a lower concentration solution would still attract mosquitos to a trap, so that more traps could be prepared from the same amount of human sweat. The % peak areas described by MEIJERINK are similar to the instantly claimed v/v percentages: MEIJERINK teaches a 1-hexanol concentration of 0.7 % of total peak area vs. 0.001-0.5 % v/v instantly claimed, and MEIJERINK teaches a decanal concentration of 0.6 % of total peak area vs. 0.0001-0.1 % v/v instantly claimed. The artisan would have reasonably prepared a 1:10 dilution of the incubated sweat composition of MEIJERINK containing 1-hexanol and decanal at concentrations of 0.07 % v/v and 0.06 % v/v. The artisan would have expected success in this dilution, because the tested concentration of incubated sweat samples caused far more mosquitos to be caught in traps as compared to fresh sweat samples.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Conclusions
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 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, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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