DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendments filed on September 15, 2023 and February 15, 2024, have been received and entered.
3. Applicant’s election with traverse of Group I on December 2, 2025, is acknowledged. The traversal is on the grounds that Group I and II should not be separated because they are related as product and process of using. This argument is not persuasive because there is a lack of unity of record that established that unity was broken with the cited art reference. Thus the Lack of Unity of record is proper and final.
Claim Disposition
4. Claims 3-4, 7, 10, 13, 16-24, 27-28, 31, 33-36, 39-47, 50-110 and 112-113. Claims 1-2, 5-6, 8-9, 11-12, 14-15, 25-26, 29-30, 32, 37-38, 48-49 and 111 are pending. Claims 1-2, 5-6, 8-9, 11-12, 14-15, 25-26, 29-30, 32, 37-38 and 48-49 are under examination. Claim 111 is withdrawn from consideration as directed to a non-elected invention.
Information Disclosure Statement
5. The Information Disclosure Statements filed on September 15, 2023 and February 15, 2024, have been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Drawing
6. The drawings filed on September 15, 2023, have been accepted by the examiner.
Specification Objection
7. The specification is objected to for the following informalities:
The specification is objected to because the priority information is missing from page 1.
The specification is objected to for the following typographical error “…honey.t” (see page 26, line 28).
Appropriate correction is required.
Claim objection
8. Claims 1-2, 5-6, 8-9, 11-12, 14-15, 25-26, 29-30, 32, 37-38 and 48-49 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite “…that [[is able to covert]]converts…”. The dependent claims hereto are also included.
For clarity and precision of claim language it is suggested that claims 2, 5-6, 8-9, 11-12, 14-15, 25-26, 29-30, 32, 37-38, 48-49 are amended to read, “The composition of claim 1, [[A composition according to claim 1,]]”.
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.
9. Claims 1-2, 5-6, 8-9, 11-12, 14-15, 25-26, 29-30, 32, 37-38 and 48-49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 claimed invention is directed to “a liquid or gel composition that comprises and enzyme that is able to convert a substrate to release hydrogen peroxide (see claim 1 in its entirety). The claims do not establish what the composition is for or amounts of the ingredients and does not define all the components such as the substrate, the enzyme and the polymer. -plastic fabric is more environmentally friendly compared to traditional textiles. The claimed invention is not commensurate in scope with the disclosure and is overly broad, especially with dependent claims reciting that the enzyme is glucose oxidase and the substrate is glucose. In addition, no correlation is made between structure and function.
The composition as claimed reads on many different types of composition, based on the breath of the claims and encompasses a large genus. A large variable genus of products, are encompassed in the claims as well as modifications that are not described. The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states 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). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
10. Claims 1-2, 5-6, 8-9, 11-12, 14-15, 25-26, 29-30, 32, 37-38 and 48-49 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 1 and the dependent claims hereto are indefinite for the recitation of “sufficient free water” and there are no indicia in the claims or the specification as to what is considered to be ‘sufficient’, what quantifiable amount. Thus, the metes and bounds of the claim is unclear.
Claims 25 and 38 are indefinite for the recitation of “substantially” because there are no indicia in the claim or specification to determine that measurable amount. The art recognizes that substantially could be 50% to 99%.
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.
11. Claim(s) 1, 5-6, 8-9, 11-12, 14-15, 25-26, 29, 37-38 and 48-49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matoke Holdings Ltd. (WO 2019/077336 A1, 2019, of record in the application).
The primary reference discloses a dispensing device comprising: a first
Chamber having or containing a composition comprising an enzyme that is able to convert a substrate to release hydrogen peroxide, and a precursor-substrate that can be converted to a substrate for the enzyme, the composition not having sufficient free water to allow the precursor-substrate to be converted to the substrate or to allow the enzyme to convert the substrate; and a second chamber having or containing water (page 2, par. 1). The composition in the first chamber is preferably a liquid comprising a non-aqueous or organic solvent, such as glycerol. The liquid may be viscous (page 5, paragraphs 3-5). The composition may comprise at least 75% by weight of the non-aqueous solvent (page 7, first paragraph). The composition is not or does not comprise honey and glycerol (page 7, par.2). The composition may comprise 1-60%, 1-50%....1-20%, 1-10% (w/v) of the substance, such as a sugar substance which can be glucose and fructose (page 8, penultimate par.). Preferably, devices of the invention do not comprise compositions formed from unrefined natural substances, such as honey (page 11, first full par. and last par.). Preferably, the compositions comprise purified enzyme and a purified substrate, which are specified from page 12, first full par.-page 16, par. 7). The compositions may comprise an antioxidant (page 17, par.6).
Therefore, the limitations of the claims are met by the reference.
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.
12. 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.
13. Claim(s) 1-2, 5-6, 8-9, 11-12, 14-15, 25-26, 29-30, 32, 37-38 and 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matoke Holdings Ltd. (WO 2019/077336 A1, 2019).
The teaching of Matoke Holdings LTD is provided above pertaining to all claims except claims 2, 30 and 32 (which are excluded from the above rejection and depend from claim 1 taught above). The limitations of the claims pertain to polymer in the composition (with characteristics around weight and amount of polymers). One of skill in the art would know the amount of PEG to use and to try different sizes and number of polymers for routine optimization. The ordinary skilled worker in the art of hydrogen peroxide releasing compositions would have immediately realized that the amount of PEG (already disclosed in the primary reference) can be increased. It would be a normal design procedure or design choice to establish the upper limit so that the composition still works as an antimicrobial composition. Further, these limitations do not appear to be the crux of the invention.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the primary reference provides the polymer and the specific one in the composition in some amount, albeit not the exact amount, but would be obvious to achieve the same. In support of this the M.P.E.P. § 2145.05 state “a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.”
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Conclusion
14. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652