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 .
DETAILED ACTION
This application is 371 of PCT/IB2022/052651.
The amendment filed on January 29, 2024 has been entered.
Status of Claims
Claims 1-2, 4-5, 8, 10, 12-15, 29-30, and 32-39 are pending.
Claims 1-2, 4-5, 8, 10, 12-15, 29-30, and 32-39 are under examination.
Foreign Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 4, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 1 and claims 2, 4-5, 8, 10, 12-15, 29-30, and 32-39 depending therefrom 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.
The term “suitable pH” in claim 1 is a relative term which renders the claim indefinite. The term “suitable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to what pH is considered as “suitable”.
Clarification is requested.
Claims 8 and 10 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.
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, claim 8 recites the broad recitation “from about 6.0” and the claim also recites “from about 6.5”, which is the narrower statement of the range/limitation. Claim 10 recites the broad recitation “from about 9.5” and the claim also recites “from about 10”. 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.
Claim 13 is 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.
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, claim 13 recites the broad recitation “from 200 rpm” and the claim also recites “from 300 rpm”, 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.
Claim 14 is 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.
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, claim 14 recites the broad recitation “from about 20 minutes” and the claim also recites “from about 30 minutes”, 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.
Claims 15 and 36-39 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 15 and 36-39 recite the limitation “estimation”. The metes and bounds of the limitation in the context of the above claims are not clear. It is unclear what aspect of the extracted pancreatic protein is subjected to “estimation”. Clarification is requested.
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.
Claims 1-2, 4-5, 8, 10, 12-15, 29-30, and 32-39 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' In this case, the examiner has broadly interpreted the claims to encompass a process for an extraction of any pancreatic protein, any lipase, any amylase, or any protease by (a) treating a pancreatic protein sample with citrate-phosphate buffer or bicarbonate buffer at any pH or the pH recited in claims 8-10 in any concentration or the concentrations recited in claims 4-5, (b) dissolving said pancreatic protein sample in said buffer, and (c) collecting the extracted pancreatic protein.
MPEP 2163 I. states that to “satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
MPEP 2163. II.A.3.(a) sates that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
According to MPEP 2163.II.A.3.(a).ii), “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The prior art discloses a process for an extraction of pancreatic protein from pancreatic protein sample, elastase from animal pancreas (abstract), comprising (a) treating the pancreatic protein sample with a bicarbonate (carbonic acid) buffer at any pH or pH of 6-9, (b) dissolving the pancreatic protein sample in the carbonic acid buffer, and (c) colleting the pancreatic protein, elastase (see Qingdao. CN 103667225 - form PTO-1449 and English Translation of CN 103667225 retrieved on September 10, 2025 – form PTO-892, page 2, “Summary of the invention” and claim 4). However, the prior art does not teach or suggest a process for an extraction of any pancreatic protein, any lipase, any amylase, or any protease by (a) treating a pancreatic protein sample with citrate-phosphate buffer or bicarbonate buffer at any pH or the pH recited in claims 8-10 in any concentration or the concentrations recited in claims 4-5, (b) dissolving said pancreatic protein sample in said buffer, and (c) collecting the extracted pancreatic protein.
The specification is limited to the description of a process of extracting a pancrelipase by (a) treating a pancrealipase granules with 100mM of citrate-phosphate buffer at a pH of 6.0 or 6.5 or 100mM bicarbonate buffer at a pH of 9.5 or 10, (b) dissolving said pancreatic protein sample in said buffer, and (c) collecting the extracted pancreatic protein as described in Example 1. While MPEP 2163 acknowledges that in certain situations “one species adequately supports a genus,” it also acknowledges that “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” In view of the widely variant species encompassed by the genus, the example described above is not enough and does not constitute a representative number of species to describe the whole genus.
Given this lack of description of the representative species encompassed by the genus of the claims, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the inventions of claims 1-2, 4-5, 8, 10, 12-15, 29-30, and 32-39.
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 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, 12, 30, and 32-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qingdao (CN 103667225 - form PTO-1449 and English Translation of CN 103667225 retrieved on September 10, 2025 – form PTO-892).
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' The limitation “suitable pH” recited in claim 1 a. is indefinite, see the 112(b) rejection above. Therefore, the limitation has been broadly interpreted as any pH.
Regarding claim 1, Qingdao discloses a process for an extraction of pancreatic protein from pancreatic protein sample, elastase from animal pancreas (abstract), comprising (a) treating the pancreatic protein sample with a bicarbonate (carbonic acid) buffer at any pH or pH of 6-9, (b) dissolving the pancreatic protein sample in the carbonic acid buffer, and (c) colleting the pancreatic protein, elastase (page 2, “Summary of the invention” and claim 4)
Regarding claim 2, the process of Qingdao is an improvement compared to the conventional extraction process that does not use a bicarbonate buffer (page 1, “Background Technology”).
Regarding claim 12, the process of Qingdao comprises dissolving the pancreatic protein sample by stirring by stirring (page 2, “Summary of the invention”).
Regarding claims 30 and 32-33, Qingdao discloses that the improved process produces 15 million units of the elastase per 1 kg of pancreas compared to production of 0.3-6.2 units of elastase per gram of pancreas using conventional processes (page 1, “Background Technology”), which equates to more than 98% yield of the elastase compared to the yield using conventional processes.
Regarding claim 34, elastase is a protease.
Regarding claim 35, Qingdao discloses that elastases are used as a pharmaceutical (page 1, “Background Technology”). Therefore, the elastase prepared from the process of Qingdao a pancreatic protein is a pharmaceutically acceptable protein.
Therefore, the reference of Qingdao anticipates claims 1-2, 12, and 34-35.
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.
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(s) 1-2, 4-5, 8, 10, 12-14, 30, and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qingdao (CN 103667225 - form PTO-1449 and English Translation of CN 103667225 retrieved on September 10, 2025 – form PTO-892) in view of Zhejiang (CN 103405756 – form PTO-1449 and English Translation of CN 103405756 retrieved on September 10, 2025 – form PTO-892).
Regarding claim 1, Qingdao discloses a process for an extraction of pancreatic protein from pancreatic protein sample, elastase from animal pancreas (abstract), comprising (a) treating the pancreatic protein sample with a bicarbonate (carbonic acid) buffer at any pH, (b) dissolving the pancreatic protein sample in the carbonic acid buffer, and (c) colleting the pancreatic protein, elastase (page 2, “Summary of the invention” and claim 4)
Regarding claim 2, the process of Qingdao is an improvement compared to the conventional extraction process that does not use a bicarbonate buffer (page 1, “Background Technology”).
Regarding claim 12, the process of Qingdao comprises dissolving the pancreatic protein sample by stirring by stirring (page 2, “Summary of the invention”).
Regarding claims 30 and 32-33, Qingdao discloses that the improved process produces 15 million units of the elastase per 1 kg of pancreas compared to production of 0.3-6.2 units of elastase per gram of pancreas using conventional processes (page 1, “Background Technology”), which equates to more than 98% yield of the elastase compared to the yield using conventional processes.
Regarding claim 34, elastase is a protease.
Regarding claim 35, Qingdao discloses that elastases are used as a pharmaceutical (page 1, “Background Technology”). Therefore, the elastase prepared from the process of Qingdao is a pancreatic protein that is a pharmaceutically acceptable protein.
Qingdao does not disclose using a citrate-phosphate buffer at the recited concentration and pH, bicarbonate at the recited pH, and stirring at the recited rate and time. However, Qingdao discloses using phosphoric acid buffers (page 2, “Summary of the invention” and claim 4)
Regarding claims 1 and 4-5, Zhejiang discloses using a citrate-phosphate buffer at a concentration of 100mM to prepare a pancreatic protein (pages 3-4, “The preparation of embodiment 1 pancreatin”).
Regarding claims 12-13, Zhejiang discloses stirring the pancreatic protein in the citrate-phosphate buffer at 200 rpm (pages 3-4, “The preparation of embodiment 1 pancreatin”).
Regarding claim 14, Qingdao discloses stirring the pancreatic protein sample in a phosphoric acid buffer for 0.5 hours 30 minutes (page 2, “Summary of the invention”).
Regarding claims 8 ad 10, Qingdao discloses adjusting the pH of the in the hydrolysis step to 6.0-9.0 (page 2, “Summary of the invention”). Therefore, it would have been well within the knowledge of one having ordinary skill in the art to vary and optimize the pH of the citrate-phosphate buffer or the pH of the bicarbonate buffer using standard techniques and protocols. Further, “[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.”, see MPEP 2144.
Therefore, in combining the teachings Qingdao and Zhejiang, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was made to modify the process of Qingdao by substituting the phosphoric acid buffer with citrate-phosphate buffer, stirring the pancreatic protein the buffer at 200 rpm for 30 minutes, and optimize the pH of the citrate-phosphate buffer and/or bicarbonate buffer. One of ordinary skill in the art at the time the invention was made would have been motivated to make the modifications in order to further improve the extraction and preparation of the pancreatic protein. Further, the normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine the optimum process for the extraction and preparation of the pancreatic protein by varying the components and reaction parameters. One of ordinary skill in the art would have had a reasonable expectation of success since Qingdao teaches a process for the extraction and preparation of a pancreatic protein by dissolving the pancreatic protein sample in a bicarbonate buffer and phosphoric acid buffer and Zhejiang teaches using a citrate-phosphate buffer for the preparation of a pancreatic protein.
Therefore, the above references render claims 1-2, 4-5, 8, 10, 12-14, and 34-35 prima facie obvious.
Claim(s) 1-2, 12, 15, 29-30 and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qingdao (CN 103667225 - form PTO-1449 and English Translation of CN 103667225 retrieved on September 10, 2025 – form PTO-892), Wezeman (US Patent No. 9,291,630 – form PTO-1449), Sanger-van de Griend (2019. Electrophoresis. 2019 Sep;40(18-19):2361-2374. – form PTO-1449), and Yang (2015. Journal of Pharmaceutical and Biochemical Analysis 109:52-61– form PTO-1449).
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' The limitation “suitable pH” recited in claim 1 a. is indefinite, see the 112(b) rejection above. Therefore, the limitation has been broadly interpreted as any pH.
Regarding claim 1, Qingdao discloses a process for an extraction of pancreatic protein from pancreatic protein sample, elastase from animal pancreas (abstract), comprising (a) treating the pancreatic protein sample with a bicarbonate (carbonic acid) buffer at any pH or pH of 6-9, (b) dissolving the pancreatic protein sample in the carbonic acid buffer, and (c) colleting the pancreatic protein (page 2, “Summary of the invention” and claim 4)
Regarding claim 2, the process of Qingdao is an improvement compared to the conventional extraction process that does not use a bicarbonate buffer (page 1, “Technical field”).
Regarding claim 12, the process of Qingdao comprises dissolving the pancreatic protein sample by stirring by stirring (page 2, “Summary of the invention”).
Regarding claims 30 and 32-33, Qingdao discloses that the improved process produces 15 million units of the elastase per 1 kg of pancreas compared to production of 0.3-6.2 units of elastase per gram of pancreas using conventional processes (page 1, “Background Technology”), which equates to more than 98% yield of the elastase compared to the yield using conventional processes.
Regarding claim 34, elastase is a protease.
Regarding claim 35, Qingdao discloses that elastases are used as a pharmaceutical (page 1, “Technical field”). Therefore, the elastase prepared from the process of Qingdao a pancreatic protein is a pharmaceutically acceptable protein.
Qingdao does not disclose using SDS-PAGE, CE-SDS, RP-HPLC, or SE-HPLC or the recited yields.
Regarding claims 15, 29, 37, and 38, Wezeman discloses estimation and/or quantification of pancreatic proteins using SDS-PAGE to determine the molecular weight of the pancreatic protein (Column 6, lines 1-14) and using RP-HPLC to the purify the pancreatic protein (Column 4, lines 45-64).
Regarding claims 15, 29, and 36 CE-SDS was also known in the art as an alternative to SDS-PAGE, as disclose by Sanger-van de Griend (abstract and page 2631, “Introduction”).
Regarding claims 15, 29, and 39, SE-HPLC was also known in the art to purify proteins based on size, as disclosed by Yang (abstract and page 52, right column).
Therefore, in combining the teachings Qingdao, Wezeman, Sanger-van de Griend, and Yang, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was made to modify the process of Qingdao by purify the elastase using RP-HPLC or SE-HPLC and/or determine the molecular weight of the elastase using SDS-PAGE or CE-SDS. One of ordinary skill in the art at the time the invention was made would have been motivated to make the modifications in order to purify the elastase and determine the molecular weight of the elastase. One of ordinary skill in the art would have had a reasonable expectation of success since Qingdao teaches a process for the extraction and preparation of a pancreatic protein by dissolving the pancreatic protein sample in a bicarbonate buffer and phosphoric acid buffer, use of RP-HPLC and/or SE-HPLC to purify proteins were known in the art, and use of SDS-PAGE, and CE-SDS to determine the molecular weights of proteins were known in the art.
Therefore, the above references render claims 1-2, 12, 15, 29-30 and 32-35 prima facie obvious.
Conclusion
Claims 1-2, 4-5, 8, 10, 12-15, 29-30, and 32-39 are pending.
Claims 1-2, 4-5, 8, 10, 12-15, 29-30, and 32-39 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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/YONG D PAK/Primary Examiner, Art Unit 1652