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 .
Priority
Acknowledgement is made of Applicants’ claim for benefit to prior filed Foreign Applications GB2104409.4 (filed 03/29/2021), GB2115496.8 (filed 10/28/2021), and GB2200186.1 (filed 01/07/2022).
Claim Status
Claims 1-22 are pending, all of which have been considered on the merits.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (FIGS 3, 11, and 12) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers in FIGS. 3, 11, and 12;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings for FIGS. 3, 11, and 12, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
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.
The Specification is objected to because the drawings are indicated by “Fig” or “Figure” rather than “FIG.” as required by 37 C.F.R. § 1.84 (u)(1) (see also MPEP §608.02 (V)).
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
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.
Claim Objections
Claims 2-7, 9-11, 16-17, and 21 are objected to because of the following informalities: “The modified adenovirus according to claim 1” should read “The modified adenovirus of claim 1,”.
Claim 8 is objected to because of the following informalities: “The modified adenovirus according to claim 7” should read “The modified adenovirus of claim 7,”.
Claim 12 is objected to because of the following informalities: “The modified adenovirus according to claim 11” should read “The modified adenovirus of claim 11,”.
Claims 13 is objected to because of the following informalities: “The modified adenovirus according claim 1” should read “The modified adenovirus of claim 1,”.
Claim 14 is objected to because of the following informalities: : “the modified adenovirus according claim 1.” should read “the modified adenovirus of claim 1.”.
Claim 15 is objected to because of the following informalities: “the modified adenovirus according to claim 1” should read “the modified adenovirus of claim 1”.
Claim 19-20 are objected to because of the following informalities: “The method according to claim 15” should read “The method of claim 15,”.
Claim 22 is objected to because of the following informalities: “The modified adenovirus according to claim 21” should read “The modified adenovirus of claim 21,”.
Claim 5 is objected to because of the following informalities: “according to any claim 1” should read “according to claim 1”.
Claim 20 is objected to because of the following informalities: “A modified adenovirus” should read “The modified adenovirus”.
Appropriate correction is required.
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, and 3-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for some embodiments, does not reasonably provide enablement for all embodiments.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of claims 1 and 3-22 encompass a modified D species human adenovirus of serotype 10 comprising: the peptide A20 inserted anywhere in the HAdV-D10 and an IC50 for CAR greater than 0.001µg/105 cells or a lack of binding to human coagulation factor X or transduction ability in the presence of serum neutralizing anti-HAdV-C antibodies. Embodiments that insert A20 into the DG loop of HAdV-10 fiber knob protein are enabled as resulting in to production of functional virus which possess the functions described above. The level of skill in the art is high and would include, e.g., Ph.D. level scientists. Embodiments that insert A20 anywhere else in HAdV-10 are not enabled as resulting in to production of functional virus which possess the functions described above.
The Specification provides examples of inserting A20 into the DG loop of HAdV-10 fiber knob protein but does not provide any working examples or reasonable direction in inserting A20 anywhere else in HAdV-10 (pg. 3 lines 30-35).
Uusi-Kerttula, et al. (Oncotarget. 2016 May 10;7(19):27926-37., hereinafter “Hanni”) provides a review of the state of the art in inserting A20 into D species human adenoviruses. The A20 peptide can only be inserted into the DG loop of HAdV-D to result in functional viruses (pg. 27927, column 2, paragraph 2) and that the A20 peptide cannot be inserted into the CD, HI, or IJ loops of a fiber knob protein from a serotype D adenovirus, HAdV-D48, as insertion of the A20 peptide into these loops resulted in the production of no infectious virus (pg. 27927, column 2, paragraph 2). Hanni demonstrates the ability to insert A20 into the DG loop of the fiber knob protein is not reasonably predictive of the ability to insert A20 anywhere else in HAdV-10 (pg. 27927, column 2, paragraph 2).
In view of the breadth of the claims, the limited teachings of the specification and the examples regarding the insertion of A20 anywhere other than the DG loop of the fiber knob protein of HAdV10 to result in functional virus, the state of the art, and the low predictability with regard to the ability of functional viruses being produced with the insertion of A20 anywhere other than the DG loop, it would require undue experimentation to create the claimed product, Amendment to the claims to require that A20 is inserted into the DG loop would overcome the rejection.
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 3, 5, and 18 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” in claim 3 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. The IC50 is rendered indefinite by use of term “about”.
The phrase “key binding residues” in claim 5 is unclear. The phrase “key binding residues” is not defined by the claim, the specification does not provide a definition, and one of ordinary skill in the art would not be reasonably apprised of the definition. It is unclear which residues are required to be lacking for the desired outcome of being unable to engage FX.
Claim 18 recites a “a method of using the modified adenovirus” in line 1 of the claim. The claim recites a use without any steps delineating how the use is actually practiced. The claim is thus rendered indefinite. See MPEP § 2173.05(q).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16-17 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitations “for use as a medicament” and “for use in the treatment of cancer” are intended uses that do not further limit the claims as they do not provide further structure to the modified adenovirus The recitation of the intended use do not result in any additional structural limitations that further limited the claimed modified adenovirus.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9-10, and 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Parker, et al. (WO 2019/158914 A1, NPL-IDS, filed, 09/29/2023, hereinafter “Parker”) and further in view of Bates, et al. (Human Gene Therapy, 01 January 2019, pg. 17-17, XP055914287, NPL-IDS, filed, 09/29/2023, hereinafter “Bates”) and Hanni.
Regarding claims 1-2, Parker teaches a modified Ad5 which is modified to include the A20 sequence (Claim 7), which was originally derived from foot-and-mouth disease virus capsid protein VP1 and has a natively high affinity to αvβ6 integrin (pg. 5 lines 21-22), instant and reference SEQ ID NO: 1 (Claim 7) and that the Ad5 lacks binding to human coagulation factor X (Claim 9). Parker does not teach that the modified adenovirus is Ad10. However, Bates teaches a vector based on Ad10 which has a lower-rate of pre-existing immunity (lines 8-9) and does not engage with coagulation Factor X, eliminating off target side effects (lines 24-25).
It would have been prima facie obvious before the effective filing date of the claimed invention for one of ordinary skill in the art to have substituted the Ad5 taught by Parker for the Ad10 taught by Bates to create a modified Ad10 comprising a binding epitope with selective affinity for αvβ6 integrin (A20). Bates provides motivation by teaching that Ad5 has limited utility due to high prevalence of pre-existing immunity and significant off target effects (lines 3-4), while Ad10 has lower rates of pre-existing immunity and no off-target effects (lines 8-9 and 24-25). One of skill in the art would have had a reasonable expectation of success for substituting the Ad5 taught by Parker for the Ad10 taught by Bates because both Parker and Bates teach adenovirus vectors for gene therapy.
Parker and Bates do not teach inserting the A20 peptide into the DG loop of HAdV-D10 fiber knob protein, as discussed above (112(a) scope of enablement rejection), the A20 peptide can only be inserted into the DG loop and result in functional virus. However, Hanni teaches that the A20 peptide cannot be inserted into the CD, HI, or IJ loops of a fiber knob protein from a serotype D adenovirus, HAdV-D48, as insertion of the A20 peptide into these loops resulted in the production of no infectious virus (pg. 27927, column 2, paragraph 2). Insertion of the A20 peptide in the DG loop of the fiber knob protein of Ad48 resulted in functional virus (pg. 27927, column 2, paragraph 2).
It would have been prima facie obvious before the effective filing date of the invention to one of ordinary skill to have inserted the A20 peptide into the DG loop of HAdV-D10 as taught by Hanni instead of the HI loop that is traditionally used for Ad5 as taught by Parker (claim 8). Hanni provides motivation by teaching that inserting the A20 peptide into loops of the fiber knob protein of serotype D adenoviruses results in non-functional viruses while insertion in the DG loop results in functional viruses (pg. 27927, column 2, paragraph 2). One of ordinary skill in the art would have had a reasonable expectation of success of inserting the A20 peptide into the DG loop of Ad10 rather than the HI loop as Hanni teaches that the DG loop of serotype D adenoviruses is the only loop that allows for functional virus production after the insertion of A20 (pg. 27927, column 2, paragraph 2).
Regarding claims 3-4, the modified adenovirus of claim 1 was rendered prima facie obvious over Parker, Bates, and Hanni as discussed above. The IC50 and CAR binding affinity would be, absent evidence to the contrary, inherent properties on the modified adenovirus. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See also MPEP 2112.01(II).
Regarding claim 5, Parker does not teach that Ad10 lacks key binding residues for FX interactions. However, Bates teaches that Ad10 is unable to engage coagulation Factor X (lines 23-24).
Regarding claim 6 Bates teaches that Ad10 is not affected by the presence of pre-existing immunity to other adenoviruses (lines 21-25).
Regarding claim 7, Parker teaches that adenoviruses can be modified to include at least one transgene encoding a therapeutic molecule or agent (claim 11).
Regarding claim 9, Parker teaches further modifying the adenovirus to include the deletion dl922-947 in the E1A gene (claim 12).
Regarding claim 10, Parker teaches further modifying the adenovirus to induce a single adenine base addition at position 445 within the endoplasmic reticulum (ER) retention domain in E3/19K (claim 13).
Regarding claim 13, Bates teaches replacing the Ad10 E4orf6 region with the Ad5 E4orf6 region to enhance production (lines 10-12).
Regarding claim 14, Parker teaches a pharmaceutical composition comprising the modified adenovirus and a pharmaceutically acceptable carrier (claim 19).
Regarding claim 15, Parker teaches a method for treating cancer comprising administering an effective amount of the modified adenovirus (claim 21).
Regarding claim 16, Parker teaches the modified adenovirus for use as a medicament (claim 14).
Regarding claim 17, Parker teaches the modified adenovirus for use in the treatment of cancer (claim 15).
Regarding claim 18, Parker teaches a method of using the modified adenovirus sin the manufacture of a medicament to treat cancer (claim 16).
Regarding claim 19, Parker teaches using the modified adenovirus to treat nasopharyngeal cancer, synovial cancer, hepatocellular cancer, renal cancer, cancer of connective tissues, melanoma, lung cancer, bowel cancer, colon cancer, rectal cancer, colorectal cancer, brain cancer, throat cancer, oral cancer, liver cancer, bone cancer, pancreatic cancer, choriocarcinoma, gastrinoma, pheochromocytoma, prolactinoma, T-cell leukemia/lymphoma, neuroma, von Hippel-Lindau disease, Zollinger-Ellison syndrome, adrenal cancer, anal cancer, bile duct cancer, bladder cancer, ureter cancer, brain cancer, oligodendroglioma, neuroblastoma, meningioma, spinal cord tumor, bone cancer, osteochondroma, chondrosarcoma, Ewing's sarcoma, cancer of unknown primary site, carcinoid, carcinoid of gastrointestinal tract, fibrosarcoma, breast cancer, Paget's disease, cervical cancer, colorectal cancer, rectal cancer, esophagus cancer, gall bladder cancer, head cancer, eye cancer, neck cancer, kidney cancer, Wilms' tumor, liver cancer, Kaposi's sarcoma, prostate cancer, lung cancer, testicular cancer, Hodgkin's disease, non-Hodgkin's lymphoma, oral cancer, skin cancer, mesothelioma, multiple myeloma, ovarian cancer, endocrine pancreatic cancer, glucagonoma, pancreatic cancer, parathyroid cancer, penis cancer, pituitary cancer, soft tissue sarcoma, retinoblastoma, small intestine cancer, stomach cancer, thymus cancer, thyroid cancer, trophoblastic cancer, hydatidiform mole, uterine cancer, endometrial cancer, vagina cancer, vulva cancer, acoustic neuroma, mycosis fungoides, insulinoma, carcinoid syndrome, somatostatinoma, gum cancer, heart cancer, lip cancer, meninges cancer, mouth cancer, nerve cancer, palate cancer, parotid gland cancer, peritoneum cancer, pharynx cancer, pleural cancer, salivary gland cancer, tongue cancer and tonsil cancer (claim 17).
Regarding claim 20, Parker teaches using the modified adenovirus to treat ovarian cancer, pancreatic cancer, oesophageal cancer, lung cancer, cervical cancer, head and neck cancer, oral cancer, cancer of the larynx, skin cancer, breast cancer, kidney cancer, and colorectal cancer (claim 18).
Regarding claims 21-22, Parker teaches using Ad5 to treat cancer (claim 15). Parker does not teach using Ad10 to treat cancer in patients with pre-existing immunity to adenoviruses. However, Bates teaches that Ad10 efficiently evades neutralization in patient ascites containing high-levels of Ad5 immunity and can be used to overcome the limitations associated with Ad5 vectors (lines 21-23 and line 28).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in absence of evidence to the contrary.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Parker, Bates, and Hanni as applied to claims 1-7, 9-10, and 13-22 above, and further in view of Coquery, et al. (WO 2019186272 A1, hereinafter “Coquery”)
As discussed above claims 1-7, 9-10, and 13-22 were rendered prima facie obvious over Parker, Bates, and Hanni.
Regarding claim 8, Parker teaches that adenoviruses can be modified to include at least one transgene encoding a therapeutic molecule or agent (claim 11). Parker, Bates, and Hanni no do not teach that the molecule encoding the transgene is cDNA. However, Coquery teaches that use of cDNA sequences is advantageous over genomic sequences (which contain introns), in that cDNA sequences can be expressed in bacteria or other hosts which lack appropriate RNA splicing systems (¶0062).
It would have been prima facie obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to have combined the teachings of Parker for an adenovirus including a transgene encoding a therapeutic molecule and the teachings of Coquery for cDNA being advantageous over genomic DNA for its ability to be expressed in bacterial systems. Coquery provides motivation by teaching that use of cDNA sequences is advantageous over genomic sequences (which contain introns), in that cDNA sequences can be expressed in bacteria or other hosts which lack appropriate RNA splicing systems (¶0062). One of ordinary skill in the art would have had a reasonable expectation of success of combining Parker, Bates, Hanni, and Coquery because they all teach adenoviral vectors.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in absence of evidence to the contrary.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Parker, Bates, and Hanni as applied to claims 1-7, 9-10, and 13-22 above, and further in view of Murali, et al. (J Virol. 2014 Jan;88(2):903-12., hereinafter “Murali”) and evidenced by Dhingra, et al. (Sci Rep 9, 1039 (2019), hereinafter “Dhingra”).
As discussed above claims 1-7, 9-10, and 13-22 were rendered prima facie obvious over Parker, Bates, and Hanni.
Regarding claims 11-12, Parker, Bates, and Hanni do not teach modifying Ad10 to include the adenovirus death protein. However, Murali teaches that ADP promotes the release of progeny virus by accelerating the lysis and death of the host cell (Abstract). As evidenced by Dhingra, ADP is only expressed in C species adenoviruses, Ad1, Ad2, Ad5, Ad6, and Ad57 (pg. 1 ¶3).
It would have been prima facie obvious before the effective filing date of the invention to one of ordinary skill in the art to have combined the teachings of Parker, Bates, and Hanni for a modified Ad10 with A20 inserted in the DG loop and the teachings of Murali for ADP from C species adenoviruses. Murali provides motivation by teaching that that ADP promotes the release of progeny virus by accelerating the lysis and death of the host cell (Abstract). One of skill in the art would have had a reasonable expectation of success at combining Parker, Bates, Hanni, and Murali because they all teach adenoviruses.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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