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 .
Claims 18-22, 24-30, 32-33, and 35, of record 6/10/2026, are pending and subject to prosecution. Claims 18, 24, 30, and 32-33 are amended. Claims 23, 31, and 34 are cancelled.
Status of Prior Rejections
RE: Objection to the specification:
The amendment to the specification is effective to obviate the objection. The objection is withdrawn.
RE: Objection to claim 31:
The cancellation of claim 31 renders the objection thereto moot.
RE: Rejection of claims 33 and 35 under 35 U.S.C. 112(b):
Claim 33 has been amended to recite steps for purifying the retrovirus. This amendment is insufficient to overcome the rejection of record, which claims “[a] method for preparing a therapeutic product, wherein the method uses a retrovirus obtained by a method for purifying retrovirus…”. The retrovirus is described using product-by-process language, the recited steps of which are not limiting in the absence of any resulting structural distinction, and no active steps are actually described in the method for preparing a therapeutic product that merely “uses” a retrovirus.
The rejection is therefore maintained.
RE: Rejection of claims 30-32 under 35 U.S.C. 101:
The cancellation of claim 31 renders the rejection thereto moot.
The applicant asserts that naturally occurring retroviruses do not inherently possess the claimed levels of impurities and that the process of purification yields retroviruses that exhibit markedly different characteristics versus naturally occurring retroviruses (Applicant Remarks, page 9). A person of ordinary skill in the art would appreciate that the claimed impurity levels constitute attributes directly related to biosafety and regulatory compliance and therefore serve to integrate the product into a specific, practical therapeutic application (Applicant Remarks, page 9). The “product” of claim 32 should be construed as encompassing a composition, formulation, or therapeutic product comprising the claimed purified retrovirus, which differentiates it from general and natural products and preparations (Applicant Remarks, page 9).
The applicant’s arguments have been fully considered but are not found persuasive. Claims 30 and 32 have been amended to recite a purified retrovirus. Purification does not result in structural changes to the retrovirus itself that would no longer qualify it as a judicial exception. As impurities, BSA and host DNA/proteins may or may not cause undesirable results or interactions on their own, but there is no indication on the record that these molecules alter retroviruses on a biophysical level. Further, intended uses—unclaimed intended uses, per the applicant’s arguments—do not actually integrate a judicial exception into any practical applications, as there are no additional elements present in the claims. See MPEP 2106.04(II)(A)(1)-(2) and 2106.07(a).
Regarding the interpretation of “product”, the words in a claim must be given their plain meaning, unless such a meaning is inconsistent with the specification. See MPEP 2111.01(I). The specification does not define “product” but rather provides “a drug or a vaccine” as two examples (See ¶0038 of the instant application’ PG Pub). The broadest reasonable interpretation of “product” as encompassing any product or preparation comprising a purified retrovirus is therefore proper, and to interpret it otherwise would be to improperly import claim limitations from the specification. See MPEP 2111.01(II).
The rejection is therefore maintained in modified form.
RE: Rejection of claims 30-33 and 35 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Shi et al. (CN 111876393 A, machine translation):
RE: Rejection of claims 30 and 32-33 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Bowles et al. (Human Gene Therapy, 1996):
RE: Rejection of claims 30 and 32-33 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Cruz et al. (Viral Vectors for Gene Therapy, 2011):
RE: Rejection of claim 33 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Hoffmann (US 644077 A):
The cancellation of claim 31 renders the rejection thereto moot.
The amendment to claim 30 is effective to obviate the rejections over Bowles et al., Cruz et al., and Hoffmann. Those rejections are withdrawn.
The applicant asserts that the method of claim 18 necessarily imparts distinct physiochemical properties to the retrovirus that differentiate it from the prior art (Applicant Remarks, page 10).
This argument is not found persuasive. There is no indication that the process by which the retrovirus is purified results in a change to the retrovirus itself. The rejection over Shi et al. is maintained.
RE: Rejection of claims 18-22, 24-25, and 27-35 under 35 U.S.C. 103 over Shi et al. (CN 111876393 A), of record, in view of Bowles et al. (Human Gene Therapy, 1996), further in view of Cruz et al. (Viral Vectors for Gene Therapy, 2011):
RE: Rejection of claims 18-22 and 24-35 under 35 U.S.C. 103 over Shi et al. (CN 111876393 A) in view of Bowles et al. (Human Gene Therapy, 1996), further in view of Cruz et al. (Viral Vectors for Gene Therapy, 2011), further in view of Venereo-Sanchez et al. (Vaccine, 2017):
The cancellation of claims 31 and 34 renders the rejections thereto moot.
The amendment to claim 18 is effective to obviate the rejections. The rejections are withdrawn.
New/Maintained Objections/Rejections
Claim Objections
Claim 21 is objected to because of the following informalities:
In line 2 of claim 21, the first instance of “in the” should be deleted, and the second instance of “reaction” should be replaced with “nuclease treatment”.
Appropriate correction is required.
Claim Interpretation
Claim 30 recites a retrovirus obtained by the method of claim 18. The retrovirus is defined using product-by-process limitations. Product-by-process claims are considered only in so far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant application, because the method of claim 18 does not distinguish the retrovirus from retrovirus generated by other methods, the retrovirus is interpreted as comprising any purified retrovirus meeting the claimed limitations.
Claim 33 recites “[a] method for preparing a therapeutic product, wherein the method uses a retrovirus obtained by a method for purifying retrovirus, comprising the following steps…”. The steps of A-D are interpreted as being part of “a method for purifying retrovirus”, which leaves the virus obtained by a method for purifying retrovirus and used in a method for preparing a therapeutic product as being described by product-by-process language, which does not distinguish the retrovirus from retrovirus generated by other methods, as stated above.
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 33 and 35 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 33 and 35 are drawn to a method for preparing a therapeutic product but fail to recite any active steps for executing the method. The steps of A-D are interpreted as being part of “a method for purifying retrovirus”, rather than being part of “[a] method for preparing a therapeutic product” which only “uses” a retrovirus obtained by the listed steps. The claims are indefinite because they attempt to claim a process without setting forth any actual steps involved in the process.
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.
Claims 30 and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
Regarding claim 30: Claim 30 is directed to a retrovirus wherein the BSA is <200 ng/ml, HCP is <1 µg/ml, and HCD is <100 ng/ml, respectively. The amounts of BSA, HCP, and HCD do not alter the structural properties of the retrovirus. Purification also does not alter the structural properties of the retrovirus. The broadest reasonable interpretation of the claimed retrovirus is therefore considered to encompass any retrovirus.
Step 1: The claim is directed to a retrovirus, which is a statutory category of matter (Step 1: YES).
Step 2A, prong 1: Retroviruses are nature-based products. When a claimed composition includes a nature-based product, further analysis is taken to determine if the claimed composition recites a nature-based product judicial exception by comparing the claimed composition to the closest naturally occurring counterpart to determine if the claimed composition has markedly different characteristics than the counterpart.
The closest naturally occurring counterpart of a retrovirus is a naturally occurring retrovirus (See Weiss, Abstract and page 1, ¶1). The claimed retrovirus reads on naturally occurring retrovirus. Thus, the retrovirus is considered to read on a product of nature judicial exception (Step 2, prong 1: YES).
Step 2A, prong 2: The claim is directed to a product and does not recite any structure that serves to integrate the compositions into a practical application (Step 2, prong 2: NO).
Step 2B: There are no additional elements required by the claim.
Claim 30 does not qualify as eligible subject matter and is rejected under 35 U.S.C. 101.
Regarding claim 32: Claim 32 is directed to a product wherein the product contains the retrovirus of claim 30. The product is not limited in any way, apart from containing the retrovirus of claim 30, which itself is interpreted as encompassing any retrovirus. The broadest reasonable interpretation of the claimed product, which lacks any other limitations, is therefore also considered to encompass any retrovirus.
Step 1: The claim is directed to a retrovirus, which is a statutory category of matter (Step 1: YES).
Step 2A, prong 1: Retroviruses are nature-based products. When a claimed composition includes a nature-based product, further analysis is taken to determine if the claimed composition recites a nature-based product judicial exception by comparing the claimed composition to the closest naturally occurring counterpart to determine if the claimed composition has markedly different characteristics than the counterpart.
The closest naturally occurring counterpart of a retrovirus is a naturally occurring retrovirus (See Weiss, Abstract and page 1, ¶1). The claimed retrovirus reads on naturally occurring retrovirus. Thus, the retrovirus is considered to read on a product of nature judicial exception (Step 2, prong 1: YES).
Step 2A, prong 2: The claim is directed to a product and does not recite any structure that serves to integrate the compositions into a practical application (Step 2, prong 2: NO).
Step 2B: There are no additional elements required by the claim.
Claim 32 does not qualify as eligible subject matter and is rejected under 35 U.S.C. 101.
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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30, 32-33 and 35 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Shi et al. (CN 111876393 A, machine translation), of record.
Shi et al. teach the large-scale purification of lentiviral vectors from cell culture supernatants (See Abstract).
Regarding claims 30, 32-33, and 35: Shi et al. teach a method for purifying lentivirus (which reads on “retrovirus”, “product”, and “therapeutic product”) for gene therapy through multiple filtration, digestion, and chromatography steps (See page 4, ¶2-8 and page 5, ¶6). Shi et al. teach that that the purified virus samples contained 0 ng/ml BSA, 17.30 ng/ml HCP or less, and 8.65 ng/ml HCD or less (See table 1).
Allowable Subject Matter
Claims 18-22 and 24-29 are allowed.
The following is an examiner’s statement of reasons for allowance:
The prior art does not teach a method for retroviral purification wherein a microfiltration step comprises filtration in a 750 kD MWCO hollow fiber filter having a membrane area of 0.16 m2 and a fiber diameter of 0.5 mm with a shear rate of 2000 s-1 followed by filtration in a 750 kD MWCO hollow fiber filter having a membrane area of 0.0115 m2 and a fiber diameter of 0.5 mm with a shear rate of 2000 s-1.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M Babic, can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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