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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-8 in the reply filed on 2/13/25 is acknowledged.
Response to Amendment
This action is written in response to applicant’s amendments received on 10/15/25.
The rejection of claims 1-7 under 35 USC 112(b) is overcome by amendment.
Any objection or rejection not reiterated herein has been overcome by amendment.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 9/16/22 has been fully considered except where references have been lined through.
Claim Rejections - 35 USC § 112
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 and 5-8 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 applications subject to pre-AJA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1-2 and 5-8 recite a “human, porcine or bovine pancreatic ribonuclease” while SEQ ID NO 1 is limiting, the open ended phrase “comprising” is used and therefore additional pancreatic ribonucleases can be used. The claims thus encompass a large genus of potential enzymes. In the case of a chemical invention, adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties (MPEP 2163). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species sufficient to show the applicant was in possession of the claimed genus (Id.). Instant specification only discloses SEQ ID NO 1, and does not disclose any structure function relationship or other information that would allow one of ordinary skill in the arts to identify any additional ribonucleases that could be used in instant invention. As the open ended phrase “comprising” is used, additional ribonucleases beyond SEQ ID NO 1 can be used in the invention. As such, the specification fails to provide sufficient written description support for the full scope of the claims.
New rejection necessitated by amendment. Claims 1-2 and 6-8 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 requires “about 100% with SEQ ID NO 1”. There is no support in the specification for “about 100% with SEQ ID NO 1. The claims thus comprise new matter.
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.
New rejection necessitated by amendment. Claims 1-2 and 6-8 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 “about 100%” in claim 1 is a relative term which renders the claim indefinite. The term “about” 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. Different persons of ordinary skill in the art may interpret the error range of the term “about” differently, leading to conflicting interpretations of what unit percent identity to SEQ ID NO 1 would infringe the claimed invention. Thus, one of ordinary skill in the art would not be able to clearly determine the metes and bounds of the claim limitation.
Regarding claim 8, The claim requires “… at least one functional molecular unit of ribonuclease activity per dosage unit”. This functional molecular unit of ribonuclease activity is not defined in the specification and could be one functional protein, one functional strand of DNA or RNA, or one mole of functional protein and therefore the scope of the claim is indefinite. Further, the method of defining ribonucleic activity is not disclosed in the specification and it is unclear how one of ordinary skill in the art would define that activity or what minimum level of activity would satisfy this limitation.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Modified rejection necessitated by amendment. Claims 1-2 and 6-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim recites a medicament comprising a pancreatic ribonuclease, a human, porcine, or bovine pancreatic ribonuclease with a pharmaceutical excipient. This judicial exception is not integrated into a practical application because the medicament comprising a pancreatic ribonuclease, a human, porcine, or bovine pancreatic ribonuclease with a pharmaceutical excipient. The pharmaceutical excipient is not defined by the claims or specification and is a generic term that can be broadly construed to encompass a range of natural products, such as salts, which would naturally occur with the natural ribonuclease. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Instant specification [0031] indicates that the claimed ribonuclease was found in hemofiltrate fractions, a product of nature. Therefore, no additional elements are present that renders the claimed process markedly different from the natural counterpart. Therefore, a pancreatic ribonuclease in particular human, porcine, or bovine pancreatic ribonuclease natural product.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any
statutory category. MPEP 2106.03. The claim recites a medicament comprising a pancreatic ribonuclease, a human, porcine, or bovine pancreatic ribonuclease with a pharmaceutical excipient for use in the treatment of regeneration of functionally impaired glomerular podocytes. Thus, the claim is to a product, which is one of the statutory categories of invention. (Step 1: YES).
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim
recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019
Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or
“described” in the claim. For a product claim, the general rule is that the claim is not subject to
the markedly different analysis for nature-based products used in the process. MPEP
2106.04(c)(I)(C). In addition, the limitation of use in the treatment of regeneration of functionally impaired glomerular podocytes comprises no steps for how the treatment will occur and therefore is not structurally limiting.
Accordingly, limitation recites pancreatic ribonuclease in particular human, porcine, or bovine pancreatic ribonuclease for use in the treatment of regeneration of functionally impaired glomerular podocytes recites a judicial exception (natural product). The limitation of a pharmaceutical excipient can be met by natural products co-occurring with the ribonuclease, such as salts. Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong
Two.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a
whole integrates the recited judicial exception into a practical application of the
exception. This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and (b) evaluating
those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application. 2019 PEG Section
III(A)(2), 84 Fed. Reg. at 54-55. The claimed product does not require any additional
elements that render the claimed product markedly different from the natural
counterpart. The claimed product requires nothing more than a human, porcine, or bovine pancreatic ribonuclease with a naturally occurring salt. Accordingly, the limitations laid
out in claim 1 do not integrate the recited judicial exception into a practical application and the
claim is therefore directed to the judicial exception. See MPEP 2106.05(h), discussing the
administration step in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78
(2012) (Step 2A: YES).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole
amounts to significantly more than the recited exception, i.e., whether any additional
element, or combination of additional elements, adds an inventive concept to the claim.
MPEP 2106.05. As discussed with Step 2A prong 2, the addition of the intended use in claim 1 is at best the equivalent of merely adding the words “apply it” as the
claimed use does not require any additional elements or structural featurs that are sufficient to amount to significantly more than the judicial exception. Further, the addition of a pharmaceutical excipient is a well-understood, conventional, and routine activity in the field of medicaments. See MPEP 2106.05(d). Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO).
Claims 1-2, and 6-8 are not eligible.
Claim Rejections - 35 USC § 102
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.
Modified rejection necessitated by amendment. Claims 1-2 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ledbetter (US8841416B2), as evidenced by Ronconi ("Regeneration of glomerular podocytes by human renal progenitors." Journal of the American Society of Nephrology 20.2 (2009): 322-332)
Regarding claim 1, Ledbetter teaches therapeutic nucleases compositions and methods (title). Ledbetter teaches the pharmaceutical composition (medicament) can comprise pharmaceutical excipients (column 3 line 66-column 4 line 2). Ledbetter teaches the nuclease can be an RNase (ribonuclease) (column 1 lines 57-67). Ledbetter teaches that the RNase can be a human pancreatic RNase (column 2 lines 57-64). Ledbetter teaches that transgenic mice expressing an RNase leads to significant reduction in glomerular tuft size (example 22). As evidenced by Ronconi, remodeling of the glomerular architecture implies regeneration of podocytes (regeneration of functionally impaired glomerular podocytes) (p329 left column first partial paragraph). Ledbetter teaches a 98.5% match to claimed SEQ ID NO 1 (about 100%, human pancreatic ribonuclease as evidenced by instant claim 3) (appendix).
Regarding claim 2, Ledbetter as evidenced by Ronconi show that the RNAse of Ledbetter can be used for regeneration of impaired podocytes, and such RNase would be capable of doing so in any disease context involving such impaired podocytes.
Regarding claim 6, Ledbetter teaches that the pharmaceutical composition (medicament) can be aqueous (column 28 lines 22-45).
Regarding claim 7, Ledbetter teaches that composition can be delivered parenterally (column 28 lines 46-51).
Regarding claim 8, Ledbetter teaches that transgenic mice expressing an RNase leads to significant reduction in glomerular tuft size (example 22). Therefore, one of ordinary skill in the arts understands that the RNase is present in at least one functional protein (molecular unit).
Response to Arguments
Applicant's arguments filed 10/15/25 have been fully considered but they are not persuasive. Applicant argues that Ledbetter does not teach a 100% match to claimed SEQ ID NO 1. (p6 2nd full paragraph). This is correct, but a 98.5% match can be considered “about 100%” as required by claim 1.
Conclusion
No claims are allowed.
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 TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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, Louise Humphrey can be reached on 571-272-5543. 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.
/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657