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 2, claims 2-10 and 12 drawn to a gene therapy vector and species of SEQ ID NO: 6 and variants having 80% sequence identity to SEQ ID NO: 6 and the species of a vector as listed in claim 8 (comprising a 5’ ITR, promoter, translation initiation sequence, CHDR1 polypeptide, polyA tail, and 3’ ITR) in the reply filed on May 8, 2026 is acknowledged.
Claims 1, 7, 9-11, 13, and 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 8, 2026.
Claim 14 has been canceled.
Claims 2-6, 8, and 12 are being examined on the merits.
Priority
The instant application is a 35 U.S.C 371 national stage filing of the International Application No. PCT/GB2022/050800 filed on March 20, 2022. The instant application claims foreign priority under 35 U.S.C 119(a)-(d) to XXX Patent Application GB2104611.5, filed on March 31, 2021. Receipt is acknowledged of a certified copy of the foreign patent application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 4, 2024 and February 23, 2026 are in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because:
Fig. 1A, indicating the genomic sequence of Cdhr1 and genotyping primers is not legible. Additionally, figure description of Fig. 1A on Pg. 4 of the specification indicates that the Cdhr1 gene is shown in yellow while the drawings are in black and white.
Fig. 1B as described in the specification on Pg. 4 indicates that primer pairs are shown in green and red while the drawings are in black and white.
Fig. 3 as described in the specification on Pg. 4 indicates depiction of autofluorescence while the drawings are in black and white.
Fig. 4, top panel, as described in the specification of Pg. 4 indicates that Fig. 4 contains colored sections (red dots and green, blue, and red bars) while the drawings are in black and white.
Fig. 5B as described in the specification on Pg. 5 indicates differences between genotypes are shown by colored boxes while the drawings are in black and white.
Fig. 8B, indicating ERG responses at various timepoints is not legible.
Fig. 9, indicating differences between genotypes in ERG responses is not legible.
Fig. 13 does not include a label for 13D which is referenced on Pg. 7 of the specification.
Figs. 18-20 depicts merged images of fluorescent staining. However the drawings are in black and white.
Fig. 49 as described on Pg. 15 of the specification indicates that differences between groups are shown in red and blue while the drawings are in black and white.
Fig. 58 as described on Pg. 17 of the specification indicates a red line corresponding to structural information. However the drawings are in black and white.
Fig. 60 as described on Pg. 18 of the specification indicates a green line corresponding to structural information. However the drawings are in black and white.
This is not intended to be a complete listing. It is recommended that Applicant carefully review the drawings and specification for other informalities.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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).
Objections to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on Pg. 32, line 11. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 recites the abbreviation CDHR1 without recitation of the full name abbreviation. It is recommended that Applicant amend the claim to recite “cadherin-related family member 1” followed by the abbreviation of CDHR1 in parentheses. 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.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Claim 2 is drawn to a gene therapy vector that expresses a CDHR1 polypeptide, therefore claim 2 is drawn to a statutory category of invention, a product, under Step 1.
The claim recites a gene therapy vector that expresses a CDHR1 polypeptide. The instant specification discloses that the CDHR1 polypeptide encompasses wild-type human CHDR1 (Pg. 30). Therefore, claim 2 is drawn to the judicial exception of a product of nature without markedly different characteristic under Step 2A, Prong 1.
This judicial exception is not integrated into a practical application under Step 2A, Prong 2 because although claim 2 recites a gene therapy vector, this recitation is considered to be a statement of intended use of the vector which expresses a CDHR1 polypeptide. As the definition of vector is broad, it encompasses any vehicle or carrier which expresses CDHR1. Per MPEP 2111.02(II), it does not appear that the recitation of a “gene therapy vector” necessarily impart a structural difference in the claimed product that expresses a CDHR1 polypeptide and therefore does not serve to limit the claim, absent evidence to the contrary.
Under the holding of Myriad, this vector which expresses a CHDR1 polypeptide is not eligible because it is not different enough from what exists in nature to avoid improperly tying up the future use and study of naturally occurring CHDR1 polypeptide. In other words, the claimed vector which expresses a CDHR1 polypeptide is different, but not markedly different, from its natural counterpart in its natural state, and thus is a “product of nature” exception. Accordingly, the claim is directed to an exception under Step 2A, Prong 1.
In regard to Step 2A, Prong 2, the instant claims are directed to the CDHR1 polypeptide expressed in a vector. With respect to Step 2A, Prong 2, limitations that may be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2A, Prong 2, limitations that were found not to be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
In regard to Step 2A, Prong 2, instant claims do not recite additional elements or a combination of elements in the claims other than the natural product itself. Specifically, recitation of a “vector” expressing CHDR1 is claimed with such a high degree of generality that it encompasses natural expression systems of a wild-type cell.
Finally, in regard to Step 2B, does the claim recite additional elements that amount to significantly more than the judicial exception. In instant case, generic vectors were well-understood, routine and conventional in the art at the time of the invention. Viewed as a whole, these additional claim elements do not provide meaningful limitations to transform the natural product into a patent eligible composition. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims to not recite additional elements beyond expression of a CDHR1 polypeptide which is a naturally occurring protein, or well-understood, routine, and conventional generic vectors under Step 2B.
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.
(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 2-6, 8, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yusef (2019, Development of AAV gene therapy for blindness caused by cone-rod dystrophy”, UK Research and Innovation, accessed from Wayback Machine on June 25, 2026, https://web.archive.org/web/20190715200226/https://gtr.ukri.org/projects?ref=MR%2FR000735%2F1, assigned a priority date of July 15, 2025 (see screenshot and July 2025 date at bottom of attached Wayback Machine entry) as evidenced by de Silva et al. (2015, Adeno-associated viral gene therapy for retinal disorders. In Gene Delivery and Therapy for Neurological Disorders (pp. 203-228). New York, NY: Springer New York, hereafter “de Silva”).
With regard to claims 2-6, Yusef discloses an AAV vector containing cadherin-1 (CDHR1) which can be used as gene therapy (3rd-5th paras.). Yusef further discloses use of an AAV8 viral vector (9th para.). This is considered to reasonably read on a gene therapy vector expressing a CDHR1 polypeptide, which is an AAV vector comprising an AAV capsid which is AAV8.
With regard to claim 8, as claimed, the chicken beta-actin promoter exon-intron-exon sequence recited in (d) and the woodchuck hepatitis post-transcriptional regulatory element recited in (f) are optional and are not considered to be limiting. Additionally, regarding the translation initiation sequence as recited in (c), this limitation has been interpreted broadly as encompassing a start codon which is considered to be inherently present in the CDHR1 polynucleotide sequence.
Yusef is silent as to the details of the vector expressing a CHDR1 polypeptide. However, the vector components comprising a 5’ ITR, a promoter operably linked to the CHDR1 polypeptide, a translation initiation sequence, a polynucleotide encoding a CDHR1 polypeptide, a polyadenylation sequence, and 3’ ITR are considered to be inherent characteristics of Yusef’s disclosed vector which would be well known to those having ordinary skill in the art as evidenced by de Silva (See MPEP 2131.01(III)). It is noted that the Yusef’s disclosure references work with Dr. Robert MacLaren (1st para. under Planned Impact) who is listed as an author on the disclosure of de Silva. de Silva discloses AAV design for gene therapy of retinal disorders and vectors comprising in a 5’ to 3’ direction a 5’ ITR, a promoter operably linked to the transgene of interest (e.g., CDHR1), a translation initiation sequence, the transgene of interest (e.g., CDHR1), a poly A tail, and a 3’ ITR (see Figs. 2a and 3).
With regard to claim 12, Yusef discloses use of the AAV8 vector for clinical trials in human subjects (6th para.) and use of gene therapy for treatment of CDHR-1 related vision loss (8th para.), which is considered to reasonably read on a pharmaceutical composition.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Issa et al. (found in IDS dated Feb 23, 2026) teaches that CDHR1 mutations are associated with retinal degeneration (Abstract). Issa et al. further teaches recent advances in gene therapy for treatment of retinal disease and that CDHR1 can be packaged into adeno-associated viral vectors which have been used for treatment of other retinal diseases (Pg. 3396, Therapeutic Implications).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
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