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 .
Priority
This application is a National Stage entry of PCT/CN2022/107811, filed 07/26/2022, and claims foreign priority to CN202110867697.2, filed 07/29/2021.
Information Disclosure Statement
The IDS filed on 5/1/2024 has been considered. See the attached PTO 1449 form.
Claim Status
Claims 12-31 are currently pending and presented for examination on the merits for patentability.
Claim Objections
Claim 12 is objected to because of the following informalities:
In claim 12, line 5, the recitation “0.001 wt% 4.0 wt%” should recite “0.001 wt% to 4.0 wt%”.
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 20-24 and 28-30 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.
Claims 20, 23-24 and 28 recite “the one or more salts of a phosphate compound”. There is insufficient antecedent basis for this limitation in the claim and this makes it unclear as to what components in the previous claims the one or more salts of a phosphate compound is referring to. Specifically, independent claims 12 and 25 recite one or more salts of a phosphoric acid compound. It is unclear whether the one or more salts of a phosphate compound (in claims 20, 23-24, 28) is referring to the one or more salts of a phosphoric acid compound recited in independent claims 12 and 25 or whether the one or more salts of a phosphate compound is different from the one or more salts of a phosphoric acid compound.
Claim 23 recites the one or more salts of a phosphate compound has a salt content of 0.01 wt% to 3.5 wt% and claim 24 recites the one or more salts of a phosphate compound has a salt content of 0.1 wt% to 1.0 wt%. It is unclear whether the salt content concentrations (wt%) recited in these claims are directed to concentration of the phosphate compound (e.g. potassium tripolyphosphate) in the disinfectant solution because phosphate is a salt of phosphoric acid, or whether the salt content refers to the concentration of potassium in the potassium tripolyphosphate because the claim recites the salt of a phosphate compound has a salt content.
Claims 21, 22, 29 and 30 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
Claim Rejections - 35 USC § 112
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.
Claim 30 is 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 30 recites the sodium hypochlorite is present at a concentration of 2.5 wt% to 2.8 wt%. Claim 30 depends from claim 25 and claim 25 recites 30 g/L (i.e. 3%) to 40 g/L (i.e. 4%) of a hypochlorite. Concentration of 2.5% to 2.8% is outside the range recited in claim 30 (i.e. 3% to 4%), therefore, claim 30 improperly broadens the subject matter of independent claim 25.
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.
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.
Claims 12-31 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN1076081A; 1993-09-15).
Li throughout the reference teaches disinfectant formulations used for sterilization/disinfection of clinical surgical instrument (medical device). Li teaches the formulation is a disinfectant aqueous solution. The disinfectant comprises hypochlorite at concentration of 0.5-2% by weight (i.e. 5 g/L to 20 g/L). Li teaches hypochlorite can include sodium hypochlorite or potassium hypochlorite. Sodium hydroxide or potassium hydroxide is included at concentration of 1-5% by weight. Potassium tripolyphosphate is also included at concentration of 2-10% by weight. (see English Translation of Li: abstract; pages 1-6; Examples; claims; entire document).
While Li does not explicitly exemplify the claimed concentrations of hypochlorite, metal hydroxides and salts of phosphoric acid, Li does disclose a general range of concentrations which overlap or merely overlap the claimed concentrations. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). See: MPEP 2144.05(I). Further, Li teaches Hypochlorite acts as a disinfectant and sterilizing agent. The addition of sodium hydroxide or potassium hydroxide is mainly used to adjust the pH of the disinfectant aqueous solution. Polyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate, act as a corrosion inhibitor. (see e.g. pages 2-3). Thus, absence any evidence of criticality of the claimed concentrations, it would have been obvious to one skilled in the art to optimize the concentrations of hypochlorite, metal hydroxides and salts of phosphoric acid to achieve these parameters disclosed by Li. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616