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 9/4/2026 has been considered. See the attached PTO 1449 form.
Claim Status
Receipt of Remarks/Amendments filed on 9/4/2026 is acknowledged. Claims 12-31 are currently pending and presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
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 (e.g. optimize the amount of hypochlorite to achieve the desired disinfectant/sterilizing effect, optimize the amount of sodium/potassium hydroxide to adjust the pH of the solution to a desired pH, and optimize the amount of polyphosphates to achieve optimal corrosion inhibition). 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.
Response to Arguments
Applicant argued that Li characterizes hypochlorite as a disinfectant and phosphoric acid salts as corrosion inhibitors but this generic characterization provides no motivation to select an increased range of hypochlorite that only abuts the maximum concentration of Li (in the case of claim 12) or exceeds Li's disclosed range (in the case of claim 25). Nor does it provide motivation to select a decreased range of tripolyphosphate that only partially overlaps the disclosed range of Li.
In response, as discussed supra, 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). Similarly, in the instant case, 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, and absence any evidence of criticality of the claimed concentrations, a prima facie case of obviousness exists. 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 (e.g. optimize the amount of hypochlorite to achieve the desired disinfectant/sterilizing effect, optimize the amount of sodium/potassium hydroxide to adjust the pH of the solution to a desired pH, and optimize the amount of polyphosphates to achieve optimal corrosion inhibition). 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).
Applicant argued that Li discloses solutions for "clinical surgical instrument sterilization" and explicitly warns against high hypochlorite concentrations, stating that if "the amount added is too large, [it] may cause corrosion of metal instruments." Li, p. 3. Li further states the "optimum percentage concentration ranges from 0.5 to 1," i.e., 5-10 g/L hypochlorite. Li, p. 3. And with respect to the tripolyphosphate corrosion inhibitor, Li identifies an "optimum percentage concentration range from 4 to 8." Li, p. 3.
In response, as discussed supra, firstly the examiner argues that Li teaches the disinfectant comprises hypochlorite at concentration of 0.5-2% by weight (i.e. 5 g/L to 20 g/L). 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. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123. Therefore, while Li in the reference discloses preferred (i.e. optimum percentage concentrations), Li in the general disclosure also teaches suitable concentrations which are broader than the preferred concentrations disclosed and which overlap or merely overlap the claimed concentrations. Further, while Li discloses that if the amount of hypochlorite added is too large, [it] may cause corrosion of metal instruments, however, Li does not disclose what amount is too large. Li teaches that the amount shouldn’t be too large to cause corrosion of metal instruments and applicant have not provided any evidence that the claimed amount of hypochlorite would cause corrosion of metal instruments and thus teach away from Li’s principle teachings.
Applicant argued the properties of the presently claimed solutions are sufficient to rebut any prima facie case of obviousness based on Li. Particularly, the present application demonstrates that such solutions are efficient and stable. Particularly, the examples of the application demonstrated that a solution as presently claimed was stable for at least 8 months in an accelerated stability experiment.
In response, Applicant's discovery of a new property or Applicant's motivation being for a different purpose or to solve a different problem is not necessarily sufficient to overcome the rejection when the structural components between the prior art and the claims are structurally the same (see, for example, MPEP 2144(IV)). Note MPEP 2144(IV): "The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).' Further, Li also teaches the disinfectant having good stability (see e.g. pages 2-3 and 5 of the English Translated copy of Li). In addition, the specification do not provide any comparative results which show that the disinfectant taught in the prior art is not stable as compared to the claimed formulation or that the claimed formulation unexpectedly provides greater stability than the prior art formulation. Absence any evidence that the claimed formulation unexpectedly provides enhanced stability compared to the prior art, applicant’s argument of finding that the claimed formulation is stable is not persuasive at this time.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALI SAEED whose telephone number is (571)272-2371. The examiner can normally be reached M-F 8-5 EST.
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, SUE X LIU can be reached at 5712725539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALI S SAEED/ Examiner, Art Unit 1616
