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 .
DETAILED ACTION
Applicant’s response filed on 07/02/2026 is duly acknowledged.
Claims 1-12 (as filed on 07/23/2024) are currently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3; drawn to “A method for manufacturing a pharmaceutical composition…”) in the reply filed on 07/02/2026 (see REM, p. 2) is acknowledged.
Claims 4-12 (non-elected invention of Group II) have been withdrawn from further considerations.
Claims 1-3 (elected invention of Group I, without traverse; directed to “A method for manufacturing a pharmaceutical composition…”) have been examined on their merits in this action hereinafter.
Priority
This application is a CIP of 16/305,039 (filed on 11/27/2018, now ABN), which is a 371 of PCT/KR2018/003011 (filed on 03/14/2018), which claims priority from Korean application KR 10-2017-0032019 (filed on 03/14/2017) and KR 10-2018-0029857 (filed on 03/14/2018).
Objection to Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see SPEC, paragraph [00116], line 5). 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. Appropriate correction is required.
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.
1. Claim 2 (as recited) is 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.
Claim 2 recites the limitation “further comprising mixing the sol-phase composition with a neuronal cell growth factor…”, which is ambiguous as it is unclear as to at when exactly “the sol-phase composition” is mixed with one of the growth factors, after “adding thrombin” step, or before said step of “adding thrombin to a sol-phase composition”? The disclosure does not provide for such explanation (see instant SPEC, p. 16, Examples “1.1. Hydrogel blend” and “1-2. Addition of neuron growth factor to hydrogel blend”, for instance), and therefore, the claimed process is deemed indefinite, as the metes and bounds of the claimed process for manufacturing the pharmaceutical composition as claimed does not appear to be properly defined. Appropriate correction and/or explanation is required.
For the prior art purposes herein, the process has been interpreted as having no order of addition requirements.
NOTE: 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.
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.
Claim 1 (as currently presented) is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arulmoli et al (2016; NPL cited in applicant’s IDS dated 07/23/2024).
Claim 1 is directed to “A method for manufacturing a pharmaceutical composition, the method comprising:
adding thrombin to a sol-phase composition comprising fibrin or fibrinogen; laminin, and hyaluronic acid or a pharmaceutically acceptable salt thereof.” (in the absence of a specific definition from applicants, the term “sol-phase” has been taken as a solution state/phase; see instant SPEC, Example 1-1)
Arulmoli et al (2016), while teaching combination scaffold of salmon fibrin, hyaluronic acid and laminin for human stem cell and vascular tissue engineering (see Title, Abstract and section 2.2, for instance), disclose a method for making a pharmaceutical composition that is in the form of a hydrogel comprising 5 mg/ml fibrin gel, which was formulated by adding thrombin enzyme solution (2U/mL in Minimal Essential Medium) to fibrinogen (5 mg/mL solution), in combination with 1 mg/mL thiolated hyaluronic acid (HA), and 100 mg/ml laminin; wherein the solutions of HA and laminin were added (to fibrinogen solution) prior to addition of thrombin to the sol-phase composition (see section “2.2. Hydrogen/scaffold formulation”).
Thus, the cited prior art reference reasonably discloses all the limitations of the claimed process for manufacturing the pharmaceutical composition as claimed.
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 1-3 (as presented) are rejected under 35 U.S.C. 103 as being unpatentable over Arulmoli et al (2016; NPL cited in applicant’s IDS dated 07/23/2024) in view of Xing et al (US 2012/0282324 A1; US-PGPUB cited in applicant’s IDS) and Spotnitz (2014; NPL cited in applicant’s IDS dated 07/23/2024).
Claim 1 is directed to “A method for manufacturing a pharmaceutical composition, the method comprising:
adding thrombin to a sol-phase composition comprising fibrin or fibrinogen; laminin, and hyaluronic acid or a pharmaceutically acceptable salt thereof.” (in the absence of a specific definition from applicants, the term “sol-phase” has been taken as a solution state/phase; see instant SPEC, Example 1-1)
The dependent claims 2 and 3 recite the following:
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Arulmoli et al (2016), while teaching combination scaffold of salmon fibrin, hyaluronic acid and laminin for human stem cell and vascular tissue engineering (see Title, Abstract and section 2.2, for instance), disclose a method for making a pharmaceutical composition that is in the form of a hydrogel comprising 5 mg/ml fibrin gel, which was formulated by adding thrombin enzyme solution (2U/mL in Minimal Essential Medium) to fibrinogen (5 mg/mL solution), in combination with 1 mg/mL thiolated hyaluronic acid (HA), and 100 mg/ml laminin; wherein the solutions of HA and laminin were added (to fibrinogen solution) prior to addition of thrombin to form the sol-phase composition (see section “2.2. Hydrogen/scaffold formulation”).
However, the method further comprising “mixing the sol-phase composition with a neuronal cell growth factor, a vascular endothelial cell growth factor…” (instant claim 2); and “wherein the pharmaceutical composition is low temperature preserved or cryopreserved in a solution at a temperature of -210 0C to 4 0C” (instant claim 3), has not been specifically disclosed by the cited prior art of Arulmoli et al, as discussed above.
Xing et al (2012), while teaching methods for promoting the revascularization and reenervation of CNS lesions (such as spinal cord injury) using topical delivery of neurotrophic growth factors via in situ cross-linkable hydrogel (see Title, Abstract, Claims; and [0064], [0074], [0085], [0116], for instances), disclose incorporation of nerve growth factor (NGF), hepatocyte growth factor, or vascular endothelial growth factor (VEGF), and others in the hydrogel composition for treating spinal cord injury (see p. 9-10, section “IV. Topical Treatment of Spinal Cord Injury”); wherein the hydrogel can comprise gelatin, collagen, laminin, fibronectin, vitronectin, and any combination thereof (see [0070]-[0073], for instance).
Spotnitz (2014), while reviewing the fibrin sealant, discloses the fact that fibrin-based biomaterials are already available in either freeze-dried or lyophilized powder kits that require reconstitution, or in the form of frozen fibrin sealant preloaded in syringes that require thawing at the time of use, and that the thawed unopened frozen pouches may also be kept for up to two weeks in a refrigerator for prompt use (see p. 6, left column, 1st paragraph).
Thus, given the detailed teachings and/or suggestions from the cited prior art references of Xing et al (for incorporation of growth factors including nerve growth factor or vascular endothelial growth factor; see teaching above) and Spotnitz (for the low temperature preservation and storage of fibrin gel pharmaceutical compositions; see teachings above), it would have been obvious to an artisan in the clinical art to successfully modify the method disclosed by Arulmoli et al for manufacturing the composition comprising fibrin such that the solution phase comprising HA, laminin along with fibrinogen is added with suitable growth factors (such as NGF or VEGF, or others) depending on the need (such as for repair and/or regeneration of CNS or spinal cord injury, etc.; see disclosure from Xing et al above), and preserved at low temperatures as already known in the art for fibrin sealants, as disclosed by Spotnitz as discussed above.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Double Patenting
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 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); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 2 (as presented) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 4-6 of co-pending Application No. 18/833,324 (reference application; filed as 371 application by common inventor and assignee on 04/09/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because amended claim dated 07/25/2024, though directed to a method of use, essentially use the same product composition as being made by the process as claimed in the instant application under examination. T
he claims 1 and 4-6 in co-pending application ‘324 are reproduced as follows:
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Since, the scope of the product being used in the co-pending application ‘324 and the product composition as currently being made in the instant application under examination are essentially the same (i.e. co-extensive in scope), and ODP rejection is deemed proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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