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 .
Claims 1-9 are pending as amended 10/10/24 and are considered herein.
Formalities:
The drawings of 10/10/24 are accepted.
The specification as amended 10/10/24 is accepted.
The IDS filings and references cited therein have been considered. A signed copy of the IDS filings is provided herewith.
Applicant’s priority is noted to be:
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Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 5 modifies the intended use of the fixative composition of Claim 1. However, Claim 1 is to the composition itself. Thus, these claims have substantially the same scope, despite a slight difference in wording.
Applicant is advised that should claim 1 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 1 and 9 both claim a composition of aqueous C2-C6 alcohol and PVP-I. Claim 9 differs in terms of being drawn to a “use”. The “use” is so broad, the substance is considered to be the same as the mere existence of the composition. Thus, despite a slight difference in wording, these claim have substantially the same scope.
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 3-4 and 9 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 3 recites “a concentration of the alcohol aqueous solution is 80 to 100 % (v/v)”. There are several issues with this recitation. First, it recites “a concentration …”, and therefore, the antecedent basis is confusion. Is this a statement of fact, of a concentration existing anywhere, or is it referring to the aqueous solution. Second, is this v/v concentration referring to only the aqueous solution of alcohol, before being mixed with the PVP-I, or when mixed with the PVP-I, or something else? Third, if the alcohol is 100%, then there is no room for aqueous water and/or PVP-I. The Artisan would not know what is being claimed.
Claim 4 recites “a concentration of the PVP-I is 0.01 to 1.0 %(v/v).” The antecedent basis is confusing. Is this the concentration in the fixative composition, or is it a statement of fact of the PVP-I composition at some point before or after being in the fixative composition?
Claim 9 is drawn to “use of a fixative…for preparing a biological sample smear”. The metes and bounds of this are so broad as to be undefined. Without a step for how it is so used, it could just be used to place under a corner leg of a desk to hold it steady while performing a preparation. In other words, it is so broad as to be undefined. Because of this, for purposes of compact prosecution, it will be considered simply in terms of the composition, similar to claim 1, and also the reason for the double patenting warning above.
Claim Objections
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.
Claim 9 is 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.
Claim 9 is drawn to a generic “use” of the composition for preparing a biological sample smear.
The specification teaches the use comprises contacting the fixative composition with the biological sample smear to fix it (e.g., section “Technical Solution”).
The Art does not know any other way to fix a biological sample, save to contact it with a fixing composition (e.g., Grizzle (2009) “Models of Fixation and Tissue Processing”, Biotech Histochem., 84(5): 185-93 (as NIH Public Access Manuscript, 12 pages long), ABSTRACT).
Thus, given the lack of knowledge provided in the specification and Art beyond contacting the fixing solution with the smear, the Artisan would not have understood Applicant to have been in possession of a generic “use” to fix a smear as presently claimed.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 2, 5, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guenezan, et al. (2021) “Chlorhexidine plus alcohol versus povidone iodine plus alcohol, … two-by-two factorial trial”, Lancet Infectious Disease, 21: 1038-48.
Claim 1: Guenezan teaches compositions of 5% povidone iodine with 69% ethanol, utilized as a disinfectant (p. 1039, blocked section, paragraph bridging columns. Povidone iodine is an alternative name for PVP-I.
Claim 2: as above, the alcohol is ethanol.
Claim 5: the intended target does not change the composition which is claimed.
Claim 9: the composition itself is deemed to anticipate the use claim. However, it is also noted that the composition was applied to tissue (e.g., ABSTRACT, Methods).
Allowable Subject Matter
Claims 6-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest art to the present claims is the compositions utilized in Guenezan, above. However, Guenezan is limited to 5% PVP-I and 69% ethanol. Claim 3 is to 80-100% alcohol and Claim 4 is to 0.01 to 1.0% PVP-I, both of which are outside the compositions of Guenezan, and the Examiner has not found reason to alter the amounts of Guenezan to predictably infringe these claims. In addition, Claims 6-8 are to a method of preparation, where biological samples are applied to a slide, which is then exposed to fixative and stain. The examiner cannot find reason to apply the compositions of Guenezan to these methods. Thus, Claims 3-4 and 6-8 are deemed free of the art.
It should be further noted that the examples provided by Applicant in the specification demonstrate several embodiments that infringe the claims but are less than optimal. However, the examiner has determined that they do work for their intended purposes, and thus, no other rejections for description or enablement are provided.
Conclusion
Claims 1-5 and 9 are rejected.
Claims 6-8 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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