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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/10/2026 has been entered.
Election/Restrictions
Claim 30 drawn to Group III (a method of treating a genetic condition using a modified cell) stands withdrawn from further consideration, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 November 2024.
Claims Status
Claim 12 is/are cancelled. Claims 1-11, 13-30 is/are currently pending with claim 30 withdrawn. Claims 1-11, 13-29 is/are under examination.
Withdrawn Rejections
The rejections of claims 1-6, 8-11, and 22-23 under 35 USC 103 over Gong, of claims 23-26 over Gong in view of Pierelli, of claims 13-16 and 18-21 over Gong in view of Pierelli and Mercadal, of claims 6-7 and 27-29 over Gong in view of Yin, have been withdrawn, as Applicant’s arguments are considered persuasive regarding composition of imidazole in nanoparticles.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
Claims 1 and 13 recite that “R19 is hydroxy alkyl substituent”; this should read “R19 is hydroxy alkyl substituted” or “R19 is a hydroxy alkyl substituent” in both claims.
Appropriate correction is required.
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 23-29 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 23-29 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 23-29 are drawn to modified host cells, without specifying whether these cells are present in an in vitro or in vivo environment. The application discloses that these cells are introduced into a human organism (see withdrawn claim 30, specification paragraph [0074]). A cell within a human organism is considered to form part of the human organism; thus, claims drawn to such cells are considered to encompass a human organism.
Claims 23-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally-occurring cells without significantly more. The claim(s) recite(s) cells which are contacted with a degradable nanoparticle comprising a ribonucleoprotein complex (RNP), which is known in the art (Kim, 2014) to quickly degrade within cells; as all components contacted to or introduced into the cells are naturally degraded, the genus of cells produced by the process described in claim 23 encompasses cells indistinguishable from naturally-occurring unmodified cells. This judicial exception is not integrated into a practical application because the cells required by claims 23-29 encompass cells materially indistinct from naturally-occurring unmodified cells. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because both the nanoparticles and the RNP contacted to or introduced into the cells degrade rapidly, resulting in cells comprising neither the RNP nor any component of the nanoparticles, nor does it meet any other considerations under MPEP 2106.05(a-h). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The only elements recited in claims 23-29 are elements which rapidly degrade within the cell, and the cells claimed by claims 23-29 are not required to comprise these elements, but are merely required to have been contacted with them; as these compositions (nanoparticles and RNPs) rapidly degrade, and the cells of the claims are not required to comprise any part of these compositions, the claims encompass cells which do not comprise any part of the nanoparticles or RNPs, and which are thus indistinguishable from unmodified cells.
Claims 23-29 recite cells, which constitute products or compositions—one of the statutory categories of invention.
Claims 23-29 recite products which encompass products of nature as described in MPEP § 2106.04(b)(II). These compositions (cells) are indistinguishable from naturally-occurring cells, as they encompass cells in which the nanoparticles and RNPs have degraded and have been thus eliminated. The specification teaches that the nanoparticles are designed to be degraded (paragraph [0405]). The art teaches that RNPs introduced into cells are known to quickly biodegrade (see Kim, 2014). As such, claims 23-29 encompass cells which have been contacted by the RNP-comprising nanoparticles of claim 1, but which have degraded both the RNPs and nanoparticles, resulting in cells indistinguishable from naturally-occurring cells.
According to Step 2A, Prong Two, set forth in MPEP § 2106.04(II)(A)(2), the claims are next evaluated with respect to whether the judicial exception is integrated into a practical application. These considerations are set forth in MPEP § 2106.05(a)-(h). This analysis turns to the additional steps or elements recited within the claims. Claims 23-29 do not recite any additional steps or elements beyond what has been determined to be a judicial exception.
There are no additional elements that reflect an implementation with a particular additional element nor is it transformed or reduced to a different state, nor which meets any other considerations under MPEP § 2106.05(a)-(h), such that the claimed composition amount to significantly more than the judicial exceptions.
For all these reasons, claims 23-29 are directed to judicial exceptions without significantly more and are rejected.
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.
Claim(s) 23-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yin (US20180187186A1, of record).
Claim 23 recites “A modified host cell prepared by contacting an unmodified host cell with the polymer nanocapsules of claim 1”. This claim and its dependent claims are considered product-by-process claims as a result, as the structure claimed is described by the process by which it is created. Therefore, the claims do not necessarily require the presence of the polymer nanocapsules, but instead the cell which results from contact with the polymer nanocapsules. Claims 23-29 are drawn to a cell contacted with a polymer nanocapsule of claim 1; the instant specification states that the polymer nanocapsules are designed to biodegrade [0405]; thus, cells having been contacted by the polymer nanocapsules may comprise the composition comprised within the nanocapsule (the RNP), but not the nanocapsule itself or its constituent parts. Furthermore, as described by Kim (2014), RNPs introduced into cells may degrade over time, eventually being entirely eliminated from these cells, rendering the modified cells indistinguishable from unmodified cells. Therefore, a cell encompassed by the modified host cell of claims 23-29 may be indistinguishable from an unmodified host cell lacking the presence of an RNP. A modified host cell of claims 23-29 also encompasses cells which do not comprise any part of the polymer nanocapsules themselves, but which do comprise an RNP.
Regarding claims 23-29, Yin teaches CD34+ hematopoietic stem cells comprising an RNP, wherein the RNP comprises a Cas9 protein and a guide RNA of SEQ ID NO:123 (SEQ ID NO:123 of Yin comprises a sequence 100% identical to instant SEQ ID NO:3 and 100% complementary to instant SEQ ID NO:38, see alignment below between SEQ ID NO:123 and instant SEQ ID NO:3) (paragraphs [0457], [0459], [0048], [0067]).
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Allowable Subject Matter
Claims 2-11, 14-22 are allowable over the prior art. Claims 1 and 13 are objected to for minor informalities, but are not anticipated nor rendered obvious by the prior art.
The following is a statement of reasons for the indication of allowable subject matter: A search of the art for imidazole-free polymer shells as claimed in the pending claims did not yield any art teaching such. In fact, the prior art taught against removing imidazole from similar nanoparticle shells (see Wang, 2018).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFRICA M MCLEOD whose telephone number is (703)756-1907. The examiner can normally be reached Mon-Fri 9:00AM-6:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram Shukla can be reached on (571) 272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/RAM R SHUKLA/ Supervisory Patent Examiner, Art Unit 1635
