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
Acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) based upon application EP22202774 filed in Europe on October 20, 2022.
With respect to instant claim 10, Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. EP22202774 and Application 18/390,310, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The limitations of claim 10 drawn to a hydroxyethyl cellulose concentration from 0.1% (w/v) to 4% (w/v) and hydroxypropyl methyl cellulose concentration from 1% (w/v) to 10% (w/v) were not included in the foreign priority documents nor the parent application. The priority date for claim 10 is the filing date, April 24, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 24, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Claim Status
Claims 1-15 are under consideration in this office action.
Claim Rejections - 35 USC § 112(b)
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 3-6, 8-11, 13, and 15 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 claims 4-6, 9, and 11 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 term “preferably” in claims 3-6, 8, 10, and 15 the phrase “more preferably” in claims 5 and 10 render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 4 and 13, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention or are merely set forth as examples. See MPEP § 2173.05(d).
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 1-3, 5-7, and 13-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 20130150285, published June 13, 2013 (“Gold”; instant PTO-892).
With respect to claims 1-2, Gold teaches therapeutic compositions comprised of calreticulin or a functional fragment or derivative thereof for the treatment acute and chronic wounds ([0009], [0021], [0035], [0086]). Calreticulin can be embedded or complexed chemically or ionically to any polymer or natural matrix that can be applied to a cutaneous wound [0029]. The composition may further comprise hydrogels and hyaluronic acid [0155]. This composition of Gold can be administered topically [0157], which reads on instant claim 2.
Gold teaches that the calreticulin is human calreticulin [0109], which reads on instant claim 3. Also, Gold teaches rabbit calreticulin amino acid sequence of SEQ ID NO: 7 [0109], which is 99% identical to instant SEQ ID NO: 1 (see alignment, where Query 1 is instant SEQ ID NO: 1 and Sbjct 1 is Gold SEQ ID NO: 7), as in the SEQ ID NO: 1 limitation of instant claim 3.
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For the topical application, the calreticulin composition can be administered at a range from about 0.001 mg to about 1 g per application [0154], which overlaps with the concentrations of instant claims 5-6.
Gold teaches that the topical formulation comprising calreticulin may be in sprayable form [0160] or applied as a gel [0155], which reads on instant claim 7.
The composition comprising calreticulin of Gold may be sterilized or mixed with preservatives [0160], which reads on instant claim 13. The composition of Gold may further comprise a growth factor [0021], antibacterial agents, or analgesics [0164], which reads on instant claim 14.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20130150285, published June 13, 2013 (“Gold”) in view of Hui et al, published April 2, 2018 (instant PTO-892).
The teachings of Gold are discussed above. Gold does not teach the limitations of instant claims 4, 8-12, and 15.
Hui et al teaches hydrogel compositions comprising the therapeutic agent acid fibroblast growth factor (aFGF), carbomer, and human serum albumin (pg 1661, section I; pg 1662, section 2.1), as in instant claims 8 and 11-12. aFGF promotes wound repair and improves the quality of wound healing (pg 1661, section I). In the aFGF composition, the concentration of the polymeric material carbomer is at 0.3-0.8 w % (Table 1 on pg 1662) and the concentration of 0.2% human serum albumin is 2 mg/ml (pg 1662, column 2, para 0) (Table 1 on pg 1662), which lie within the ranges polymeric material and serum albumin of instant claims 9 and 11, respectively.
The stability of the composition of Hui et al was assessed at -20 °C, 5 °C, and 25 °C (pg 1662, column 2, section 2.5), as in the storage temperatures of instant claim 15.
Although Gold nor Hui et al explicitly recite the limitation wherein the serum albumin protein is recombinant, it is the Office’s position that this species within the serum albumin protein genus can be at once envisaged from the prior art because the species within this genus (e.g., plasma derived and recombinant) are sufficiently limited and well delineated; see MPEP 2131.02(III) and In re Petering (wherein the courts determined that a reference describing a generic formula encompassing about 20 compounds was found to anticipate each of the 20 species without specifically naming them).
Given that Gold teaches a composition comprising calreticulin protein and polymeric materials for topical wound treatment and further given that Hui et al teach compositions comprising a therapeutic and carbomer hydrogel and serum albumin protein for topical wound treatment, it would have been obvious to one of ordinary skill in the art to substitute the therapeutic aFGF of Hui et al with the calreticulin protein of Gold. The motivation comes from Hui et al, who teaches that the topically administered therapeutic composition further comprising carbomer and serum albumin achieved much better biostability than a composition without carbomer (pg 1667, Section 5). KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses combining prior art elements according to known methods to yield predictable results; the combination is obvious unless its application is beyond that person's skill. It would have been within the technical grasp of the ordinary artisan to apply the calreticulin protein in the improved composition of Hui et al to obtain predictable results. Such amounts to combining prior art elements according to known methods to achieve predictable outcomes. In the absence of unexpected results or a teaching away in the prior art, the claims are obvious over the combined teachings of Gold and Hui et al.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20130150285, published June 13, 2013 (“Gold”) in view of Hui et al, published April 2, 2018, as applied to claims 1-9 and 11-15 above, and further in view of Braund et al, published March 2007 (instant PTO-892).
The teachings of Gold in view of Hui et al are discussed above. This combination of references does not teach a composition comprising calreticulin protein and the polymeric material hydroxypropyl methyl cellulose at a concentration from 1%-10% (w/v).
Braud et al teaches that hydroxypropyl methyl cellulose (i.e. “Hypromellose”) has been used for years in sustained-release pharmaceutical products (pg 365, para 2). Braud et al teaches compositions comprising hypromellose and growth factor for the prolonged release of topically applied growth factors to an underlying wound (pg 368, para 0-1). The hypromellose gels comprised 7% w/v hypromellose (pg 368, para 1), as in the w/v of hydroxypropyl methyl cellulose of instant claim 10.
Given that Gold in view of Hui et al teach a composition comprising calreticulin protein, a growth factor, and the polymeric material carbomer, and further given that Braud et al teaches compositions comprising hydroxypropyl methyl cellulose and growth factor for the topical delivery of a pharmaceutical product, it would have been obvious to one of ordinary skill in the art to apply the polymeric material of Braud et al in the composition of Gold in view of Hui et al and have a reasonable expectation of successfully generating the claimed stabilized pharmaceutical formulation. The motivation to do so comes from Braud et al, who teaches that growth factors in chronic wound conditions are present at too low concentrations and need to be protected from premature clearance, hence the need to create sustained-release formulations (pg 367, para 1). The substitution of hydroxypropyl methyl cellulose for carbomer would amount to the use of a known technique (i.e. the polymeric material of Braud et al) to improve a similar product (i.e. the product of Gold in view of Hui et al) in the same way, see MPEP 2143.
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.
Claim 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/390,310 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same pharmaceutical composition comprising calreticulin protein and the same polymeric materials.
Claims 1-7 of ‘310 teach a pharmaceutical composition comprising calreticulin of SEQ ID NO: 1 or recombinant calreticulin, at a concentration from 1 mg/ml to 10 mg/ml, and a polymeric material at a concentration from 0.5-10% (w/v/), wherein the composition is a hydrogel spray, as in instant claims 1-7. Claims 7-8 of ‘310 teaches the species of polymeric material and their concentrations of instant claims 8-10. Claims 9-10 of ‘310 teach the serum albumin limitations of instant claims 11-12, and claims 12-13 of ‘310 teach the preservatives and biologically active agents of instant claims 14-15. Claim 14 of ‘310 teaches the storage conditions of instant claim 14.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
