DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 57-63 are currently pending in this US patent application and were examined on their merits.
Information Disclosure Statement
The 41-page information disclosure statement filed 12/18/2024 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
The 41-page IDS filed 12/18/2024 is provided on a form with no boxes filled in other than those containing citation information. This document does not identify itself as an information disclosure statement or provide heading information regarding the contents of the form to provide necessary context for the information contained therein. Please resubmit this IDS on a form that labels the rows and columns appropriately.
The 2-page IDS filed in this application on 12/18/2024 has been received and considered.
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 58 and 60 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 58 and 60 contain the trademark/trade name ‘phytone.’ Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the brand of peptone used in the instant method and, accordingly, the identification/description is indefinite. Therefore, claims 58 and 60 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted “phytone peptone” in claims 58 and 60 to be any peptone.
Claim Interpretation
Claim 57 recites a step of culturing Clostridium histolyticum in a medium containing particular ingredients “to thereby reduce clostripain production.” The preamble of this claim recites a method “of producing collagenase and reducing clostripain from Clostridium histolyticum.” Claim 61 recites the method of claim 57, wherein clostripain production is reduced compared to a culture process using a different culture medium. Claim 62 recites the method of claim 57, wherein the collagenase comprises collagenase I and collagenase II. These statements in the bodies of claims 57 and 61-62 and in the preamble of claim 57 represent the intended results of practicing the method steps of claim 57. A clause in a method claim does not receive weight when it simply expresses the intended result of a process step positively recited. See MPEP § 2111.04 (I). As such, any prior art that reads on the positively recited steps of claim 57 (i.e., culturing, harvesting, and purifying) will be interpreted to read on the entirety of claim 57, as well as on claims 61-62.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 57-58 and 61-63 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Berman et al., J. Bacteriol. 82(4): 582-588 (1961), as evidenced by Alreshidi et al., Frontiers in Microbiology 10: 3059 (2020).
Berman teaches culturing Clostridium histolyticum in a medium containing trypticase soy broth and proteose peptone (see entire document, including page 582, right column, paragraph 3, to page 583, left column, paragraph 1; reads on claims 57-58 and 61-63; see above under Claim Interpretation and Claim Rejections – 35 USC 112 for the Examiner’s interpretations of claims 58 and 61-62; the Examiner further notes that claim 63 does not specify any distinctions between various “stages,” “aliquots,” or “inoculating” or “incubating” steps, and so a single step of inoculating the culture medium with C. histolyticum, as required by Berman’s teaching, would read on all of the various “stages,” “aliquots,” and “inoculating” and “incubating” steps of claim 63 and would also inherently result in “agitating” the mixture to at least some degree by the addition of one substance to another). The culture media were then removed from the containers in which they were incubated and passed through a Selas filter to obtain cell-free filtrates (page 584, left column, paragraph 2) that contained collagenase (page 586, left column, paragraph 2; reads on claims 57 and 61-62).
Alreshidi teaches that trypticase soy broth contains tryptophan, glutamine, and asparagine (see entire document, including page 3, left column, paragraph 2 and Table 1). As such, the culture medium of Berman, which contained trypticase soy broth, inherently contained glutamine, tryptophan, and asparagine, as recited in instant claim 57.
Therefore, claims 57-58 and 61-63 are anticipated by Berman, as evidenced by Alreshidi, and are rejected under 35 U.S.C. 102(b).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 57-63 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Berman et al., J. Bacteriol. 82(4): 582-588 (1961), as evidenced by Alreshidi et al., Frontiers in Microbiology 10: 3059 (2020).
As discussed above, claims 57-58 and 61-63 are anticipated by Berman, as evidenced by Alreshidi. In addition, Berman teaches the presence of pantothenate, nicotinic acid, pyridoxine, thiamine, and riboflavin in the culture medium (page 585, left column, Table 2), which are substances found in yeast that can, therefore, be interpreted as “yeast extract” as recited in instant claim 60. However, Berman does not teach the particular amounts of the various medium components recited in instant claims 59-60.
While Berman does not teach the particular amounts of the various medium components recited in instant claims 59-60, the instantly recited concentrations would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of all of the culture medium components of Berman because the concentrations of ingredients in a culture medium are art-recognized, result-effective variables known to affect the growth of the cells and their production of useful substances, which would have been optimized in the art to provide the desired amount of cell growth and production.
Therefore, claims 57-63 are rendered obvious by Berman, as evidenced by Alreshidi, and are rejected under 35 U.S.C. 103(a).
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that 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 was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 06/23/2026
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