DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Reply filed 14 July 2026, Applicant did not amend the claims. Claims 1-20 are pending.
Improper Divisional
Applicant has misidentified the present application as a divisional of Application No. 16/843,114. Claims 1-14 of the present application are directed to elected Group I of the ’114 Application, which concerns a method of changing an oxidation-reduction (redox) state of a cell undergoing or at risk of undergoing hypoxia. To remedy this matter, Applicant must correct the claim of benefit. The examiner notes that this application may constitute a continuation. As a courtesy, Applicant is referred to MPEP § 211.02(a), which concerns correcting or adding a benefit claim after filing. Applicant can correct the claim of benefit by (i) amending the specification, (ii) submitting a Corrected Application Data Sheet (ADS), and (iii) filing a Request for Corrected Filing Receipt. MPEP § 211.02(a).
Restriction/Election
The examiner acknowledges Applicant’s election with traverse of Group I, which consists of claims 1-14. Reply (14 July 2026) at pp. 1-2. In response, the examiner confirms that claims 15-16 are properly directed to Group II because they concern treating a subject for hypoxia. In both those claims, the noble metal precursor is actually administered to the subject, in contrast to claims 1-14, which do not require (or even encompass) administration to a subject. Instead, claims 1-14 require administration to a cell. Claims 15-16 conflict with claims 1-14 and, consequently, fail to comply with 35 U.S.C. 112(d). This is one of the reasons why the examiner recommended that Applicant redraft claims 15-16 in independent form or in a form that depends on claim 17 of Group II.
Group I is classified primarily in A01N 1/10 (preservation of living parts), and Group II, which consists of claims 15-18, is classified primarily in A61P 39/06 (specific therapeutic activity: general protective or antinoxious agents - free radical scavengers or antioxidants). The restriction requirement is proper because it complies with MPEP § 806.05(j) and is necessary to enable the examiner to adequately focus his search and, thereby, avoid incurring an undue search and examination burden. MPEP § 808.02(A) and (C). Accordingly, the restriction requirement is made FINAL.
Claims 15-20, which are respectively directed to non-elected Groups II and III, are withdrawn from further consideration. 37 CFR 1.142(b).
The examiner additionally acknowledges Applicant’s election of the following six species: (1) gold trichloride (AuCl3); (2) brain cell; (3) cell in a tissue or organ that is being preserved for transplantation; (4) human; (5) stroke; and (6) intravenously. The examiner confirms that the election-of-species requirements are proper because they are necessary to enable the examiner to adequately focus his search and, thereby, avoid incurring an undue search and examination burden. MPEP § 808.02(A) and (C). For example, the three genera of noble metal precursors, cells, and subjects are each vast and diverse. Accordingly, the election-of-species requirements are made FINAL.
At this juncture, the examiner notes that his search located relevant prior art directed to a non-elected species of noble metal precursor, specifically, chloroauric acid (HAuCl4), which — along with gold trichloride (the elected species) — is recited in the Markush group of claim 10. Accordingly, the corresponding election-of-species requirement is withdrawn as to between chloroauric acid and gold trichloride only.
The examiner additionally notes that his search located relevant prior art directed to two non-elected species of cell, specifically, kidney cell and cardiac cell, which — along with brain cell (the elected species) — are recited in the Markush group of claim 12. Accordingly, the corresponding election-of-species requirement is withdrawn among kidney cell, cardiac cell, and brain cell only.
Claim 13, which is directed to a non-elected species of cell type, is withdrawn from further consideration. 37 CFR 1.142(b).
Claims 1-12 and 14 are considered below.
Claim Rejections - 35 U.S.C. 102(a)
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102(a) that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless
(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; or
(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 1-12 are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Anshup (“Growth of gold nanoparticles in human cells.” Langmuir 21.25 (2005): 11562-11567).
Anshup is directed to the “Growth of Gold Nanoparticles in Human Cells.” Title.
Anshup discloses that gold nanoparticles were synthesized within HEK-293 cells by incubating them in HAuCl4 (chloroauric acid) solution. Abstract and page 11563. The examiner notes that (i) HEK is the abbreviation for “human embryonic kidney” and (ii) chloroauric acid is identified as a noble metal precursor in claim 10 of the present application.
Anshup discloses that in addition to HEK-293 cells, which are non-cancerous, three cancerous cell lines were incubated with in HAuCl4 solution. Abstract and pages 11562-63. Anshup discloses that the cancerous cells are resistant to hypoxia, which is one of three significant differences between them and the HEK-293 cells. Page 11566 (right column). Stated another way, the HEK-293 cells are not resistant to hypoxia and, therefore, qualify as “undergoing or at risk of undergoing hypoxia” (claim 1). MPEP § 2111 (“During patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’”).
Anshup discloses: “Cells were grown to ∼80% confluency starting with 3 × 105 cells per well in 6-well tissue culture plates (2 wells for each cell line) in Dulbecco's Modified Eagle Medium (DMEM) supplemented with 10% fetal bovine serum (FBS) and incubated at 37°C in humidified atmosphere containing 5% CO2.” Page 11563 (left column). “A total of 3 mL of 10-3 M HAuCl4 solution prepared in PBS, pH 7.4 and filter sterilized using MILLEX GV Durapore PVDF membrane filter (pore size: 0.22 μm), was added to each well.” Id. The forgoing qualifies as an “effective amount” (claim 1) of HAuCl4.
The purpose recited in the preamble of claim 1 — i.e., “changing an oxidation-reduction (redox) state of a non-cancerous cell” — does not result in a manipulative difference between the claimed invention and the prior art (Anshup) and, therefore, is not considered limiting. MPEP § 2111.02(II).
In sum, claims 1, 8-10, and 12 are anticipated by Anshup.
Regarding claims 2-7 and 11, the limitations recited in each of these claims do not result in a manipulative difference over the prior art, as applied above to claim 1. MPEP § 2111.04(I) (a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited’”), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003). The examiner notes that “a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” MPEP § 2112(I).
Claims 1-8, 11-12, and 14 are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Gordon (US 4,829,984).
Gordon is directed to the “Method for the improvement of transplantation techniques and for the preservation of tissue.” Title.
Gordon discloses: “The instant invention relates to a method for the improvement of the transplantation process. Through the application of this process, particles which are ferromagnetic, paramagnetic, or diamagnetic are introduced into the donor tissue either prior to, during, or after ex-plantation.” Column 3, lines 18-23. “Particularly useful particles include both inorganic elements and compounds as well as metal containing organic compounds.” Column 5, lines 19-21. Gordon identifies platinum as a suitable metal. Column 5, line 42; column 11 at claim 11; and column 13 at claim 28. The examiner notes that platinum is identified as a noble metal precursor in claim 8 of the present application.
Gordon discloses that the particles can be introduced into the organ of transplant (column 4, lines 22-23) and identifies the heart as an exemplary organ. Column 9, lines 24-58. An effective amount of 0.3 ml (8 mg/ml) is disclosed in lines 55-56 of column 9. It is axiomatic that an isolated heart or other organ is hypoxic or at risk of undergoing hypoxia, especially considering it is no longer connected to the circulatory system of the organism from which it originated.
The purpose recited in the preamble of claim 1 — i.e., “changing an oxidation-reduction (redox) state of a non-cancerous cell” — does not result in a manipulative difference between the claimed invention and the prior art (Gordon) and, therefore, is not considered limiting. MPEP § 2111.02(II).
In sum, claims 1, 8, 12, and 14 are anticipated by Gordon.
Regarding claims 2-7 and 11, the limitations recited in each of these claims do not result in a manipulative difference over the prior art, as applied above to claim 1. MPEP § 2111.04(I) (a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited’”), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003). The examiner notes that “a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” MPEP § 2112(I).
Claim Rejections - Double Patenting (Non-Statutory)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminalDisclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/ eTD-info-I.jsp.
Claims 1-12 and 14 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-12 of Patent No. 12,048,714.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 1 of the ’714 Patent, which is directed to “a method of preserving an isolated cell, tissue, or organ ex vivo for transplantation,” discloses “administering ex vivo to the isolated cell, tissue, or organ an effective amount of a noble metal precursor.” It is axiomatic that an isolated cell, tissue, or organ is hypoxic or at risk of undergoing hypoxia, especially considering it is no longer connected to the cardiovascular or other circulatory system of the organism from which it originated. Conflicting claim 6 discloses each of the gold chloride precursors recited in claim 10 of the present application. Similarly, conflicting claim 7 discloses each of the cell types recited in claim 12 of the present application. In sum, the present claims are not patentably distinguishable over conflicting claims 1-12 of the ’714 Patent.
Conclusion
Claims 1-12 and 14 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
25 July 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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