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 .
Claim Objections
Claim 1 recites “characterized in that it is in the solid or semi-solid form” and should be amended to recite “characterized in that said composition is in the solid or semi-solid form” so as to improve clarity.
Claim 4 recites “wherein said composition is a tablet” and should be amended to recite “wherein said composition is in the form of a tablet”.
Claim 5 recites “wherein said composition is a powder formulation packaged in single-dose sachets” and should be amended to recite “wherein said composition is in the form of a powder formulation packaged in single-dose sachets”.
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 1-7 and 9-11 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 recites the limitation "the solid or semi-solid form". There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to recite “a solid or semi-solid form”.
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, Claims 1 and 11 recite the broad recitation “biological”, and the claim also recites “histological” which is the narrower statement of the range/limitation. 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. Examiner suggests Applicant merely recite “biological” and omit “histological”, “cytological”, and “autopsical” as each of these terms appears to overlap and encompass one another under a broadest reasonable interpretation.
Further, Claim 9 recites the broad recitation “dispersing”, and the claim also recites “dissolving” which is the narrower statement of the range/limitation. 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. Examiner suggests Applicant merely recite “dissolving” and omit “dispersing” and “disintegrating” as each of these terms appears to overlap and encompass one another under a broadest reasonable interpretation.
Claim 9 further recites “an appropriate amount of an appropriate solvent or solvent mixture” wherein it is entirely unclear what metes and bounds constitute the relative appropriateness of the “appropriate amount” and the “appropriate solvent”. One of ordinary skill in the art would have no way of determining if a prospective solvent is appropriate or if the amount used is appropriate given that the claim fails to provide any sufficient guidelines to inform one skilled in the art as to what is meant by the “appropriate” amount and solvent.
Claim 10 recites the limitation "the staining solutions obtainable from said solid compositions". There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to recite “
Claim 10 recites the limitation " said solid compositions". There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to recite “said
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.
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 1-3, 5-7, and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anand et al. (US 2019/0310271 A1), hereinafter “Anand”.
Regarding Claim 1, Anand teaches a composition for the preparation of staining solutions intended to be used (Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II).) in the contrast histochemical staining of biological, histological, cytological and autopsical samples ([0007]: “the present invention features methods, systems, and compositions for delivering antibodies, stains, or other reagents to a tissue sample”), characterized in that it is in the solid or semi-solid form (See para. [0012] discussing the deposition of the solid stain reagent.) and comprises at least one staining substance ([0006]: “In some embodiments, the reagent (e.g., antibody, probe, stain, enzyme, etc.)...”) and one or more additives ([0005]: “The compositions comprise a water-soluble polymer (e.g., a film, a pouch, a wafer, etc.) and the reagent. In some embodiments, the reagent is infused, printed, embedded, or encapsulated in the water-soluble polymer.”) and/or one or more excipients ([0025]: “In some embodiments, the composition comprises two or more reagents...In some embodiments, the solid composition further comprises salts from a buffer.”), as in Claim 1.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Anand teaches the composition discussed above wherein said at least one staining substance is selected from hematoxylin, eosin, OG6, Light Green and mixtures thereof ([0046]: “Examples of counterstains include chromogenic nuclear counterstains, such as hematoxylin (stains from blue to violet)...non-nuclear chromogenic stains, such as eosin (stains pink)...”), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Anand teaches the composition discussed above wherein said one or more additives are selected from an oxidizer and/or a mordant and/or phosphotungstic acid (Para. [0125] discusses substances to be included in the composition and incorporates U.S. Pat. Publ. 2013/0260379 (Alexander et al.) by reference, which suggests using hydrogen peroxide (an oxidizer) as the buffering additive in a staining solution (See Alexander et al. para. [0106].). Thus, Anand reasonably suggests the taught composition wherein said one or more additives is an oxidizer.), as in Claim 3.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Anand teaches the composition discussed above wherein said composition is a powder formulation packaged in single-dose sachets ([0006]: “In some embodiments, the reagent (e.g., antibody, probe, stain, enzyme, etc.) is infused between at least two layers of the water-soluble polymer film.”), as in Claim 5.
Regarding Claims 6 and 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Anand teaches the composition discussed above wherein said composition constitutes a ready-to-use unit for the preparation of said staining solutions in a volume ranging from 10 mL and 5 L, and wherein said composition constitutes a ready-to-use unit for the preparation of 500 mL of said staining solutions (As discussed above regarding Claim 1, the composition of Anand is provided as ready-to-use units to dissolve in a volume of liquid on a microscope slide. Such a ready-to-use unit in Anand is fully capable of dissolving in a volume ranging from 10 mL and 5 L, and 500 mL. Applicant’s providing that the purpose of the composition is to prepare particular volumes is drawn to a mere intended use. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II).), as in Claims 6 and 7.
Regarding Claim 9, Anand teaches a method for the preparation of staining solutions, said method comprising dispersing and/or disintegrating and/or dissolving the composition of claim 1 within an appropriate amount of an appropriate solvent or solvent mixture ([0153]: “The puddle of reaction buffer on top of the slide dissolved the PVA, releasing the antibody and enabling staining with the primary antibody.”), as in Claim 9.
Regarding Claim 10, Anand teaches a kit comprising two or more compositions of claim 1 ([0043]: “The present invention also features kits comprising one or more solid compositions.”), as in Claim 10.
Further as in Claim 10, Anand does not specifically discuss including in the kit “the related instructions for the preparation of the staining solutions obtainable from said solid compositions”, as in Claim 10. However, the recited “instructions” constitutes printed matter lacking a new and nonobvious functional relationship with the claimed kit components and, therefore, is not entitled to patentable weight or sufficient to distinguish the claimed kit from the prior art – see MPEP 2111.05. Further, one of ordinary skill in the art would find it obvious to provide the kit of Anand comprising instructions, as is common practice with reagent preparation kits.
Regarding Claim 11, the prior art meets the limitations of Claim 9 as discussed above. Further, Anand teaches the method discussed above wherein the staining solution stains biological, histological, cytological and autopsical samples ([0008]: “histological examination on a slide” – [0107]: “histological staining” – Such thinly sliced tissue samples examined by Anand represent biological, histological, cytological, and autopsical samples. Further, this claim is fully drawn to an intended use. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II).), as in Claim 11.
Claim Rejections - 35 USC § 103
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 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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Demos et al. (US 2021/0063312 A1), hereinafter “Demos”. Anand has been discussed above.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Anand does not specifically teach the composition discussed above wherein the composition is a tablet, as in Claim 4.
However, Desmos teaches a respective staining composition wherein “the formulation of mix dyes, such as in powder form, that can be fabricated in a small tablet form” ([0071]). Therein, Desmos describes this arrangement as being a rapid and simple means for preparing test solutions ([0071]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the composition of Anand wherein the composition is a tablet, such as suggested by Desmos, so as to provide a rapid and simple means for preparing test solutions having a pre-measured amount of stain, thereby helping to reduce human errors.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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