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
This application filed 06/28/2024 Claims Priority from Provisional Application 63511035 , filed 06/29/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/18/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 8 is objected to because of the following informalities: Examiner respectfully requests Applicant to add ELP in parenthesis in line 1, for consistency with the abbreviation that follows. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: Examiner respectfully requests correction of ‘flower-liked shaped’ in line 1, to ‘flower-like shape’. 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.
Claims 1-5, 13-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (natural product) without significantly more.
Regarding claim 1, the claim(s) recite(s) the judicial exception of ‘polypeptide substrate and calcium ions’. This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance from the claimed composition and naturally occurring Ca2+ binding proteins in nature. Matilda Yanez et al., hereinafter Yanez (Matilda Yanez et al., Calcium Signaling, Chapter 19-Calcium binding proteins, 01 January 2012) teaches numerous, naturally occurring Calcium binding proteins -notably the EF hand domains (12 amino acid) located in calmodulin, troponin C, calcineurin etc., that bind calcium (see Fig 19.1). Yanez teaches, that several -membrane and soluble Ca2+ sensor proteins have been identified. These proteins undergo a conformational change in response to physiological fluctuations in extracellular Ca2+ concentrations; the conformational change (i.e. disorder/order) allows interactions with a specific target protein, ultimately modulating its function (see 2nd paragraph in section ‘Extracellular Ca2+ binding proteins’).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional claim elements do not integrate the judicial exception into something more.
See the following analysis:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or
abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes, the claim recites a composition. Under the broadest reasonable interpretation, the claimed
composition, is a naturally occurring calcium binding protein that is naturally occurring.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The claim is directed only to a composition comprising a polypeptide and calcium ions.
Regarding claim 2, the rejection is noted above.
Regarding claim 3, in addition to the rejection noted above, Chloride and Calcium are naturally occurring ions in the human body.
Regarding claim 4, in addition to the rejection noted above, Yanez teaches, (see section ‘Smooth Muscle Sarcoplasmic and Endoplasmic Reticulum’, 3rd paragraph) calreticulin C-terminal domain (residues 291–400) accounts for the high capacity (∼20 mol Ca2+/mol of protein) and low affinity (Kd ∼2 mM) Ca2+-binding activity (i.e. at least 0.001 % by weight of substrate).
Regarding claim 5, in addition to the rejection noted above, Yanez teaches, (see section ‘Smooth Muscle Sarcoplasmic and Endoplasmic Reticulum’, 3rd paragraph) calreticulin C-terminal domain (residues 291–400) accounts for the high capacity (∼20 mol Ca2+/mol of protein) and low affinity (Kd ∼2 mM) Ca2+-binding activity (i.e. at least 0.005 – 1.5 % by weight of substrate).
Regarding claim 13, the claim(s) recite(s) the judicial exception of ‘a crystal’. This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance from the claimed composition and naturally occurring crystals facilitated by calcium-binding proteins in nature. Maria Sklodowska (Maria Sklodowska, Biomolecules 2018, 8(2), 42) teaches Amylogenin, which constitutes the majority of immature enamel which undergoes extracellular self-assembly that requires calcium and phosphate. Amylogenin acts both as an extracellular scaffold for mineral crystal formation and as a factor controlling the direction of crystal growth (see section 4.2.1, last few lines).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional claim elements do not integrate the judicial exception into something more.
See the following analysis:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or
abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes, the claim recites a composition. Under the broadest reasonable interpretation, the claimed
composition, is a naturally occurring calcium binding protein crystal that is naturally occurring.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The claim is directed only to a crystal comprising polypeptide and calcium ions.
Regarding claim 14, the rejection is noted above, under the rejection for claim 13. Also see Table 1 in Maria Sklodowska.
Regarding claim 15, the rejection is noted above. Also see Table 1 in Maria Sklodowska.
Regarding claims 16-22, the rejection is noted above in the rejection under claim 15. Additionally, see tooth enamel architecture and crystal orientations (Theresa, News from Berkeley Lab-Dec 23, 2019).
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-10, 13-24 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Sherif Ahmed Abdelsalam et al., hereinafter Abdelsalam (Sherif Ahmed Abdelsalam et al., US11965016B2, Filed: Jan 31, 2022).
The applied reference has a common Inventor and Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Abdelsalam teaches a composition comprising hierarchically ordered crystal structures comprising the step of contacting a protein scaffold membrane with a solution of mineralizing ions (see Col 3, lines 14-16). Mineralizing solution comprises calcium and contains from about 0.1 mM Ca2+ to about 1 M Ca2+ (see Col 25, line 17). Specifically, Abdelsalam teaches (see Fig 20 legend) statherin-ELP (i.e. polypeptide) and Calcium solution (i.e. Calcium ions), evidencing the strong calcium binding to the statherin-ELP polypeptides.
Regarding claim 2, Abdelsalam teaches Ca2+ as noted above (see Col 25, line 17; Fig 20 legend).
Regarding claim 3, Abdelsalam teaches Ca2+ but does not specifically teach that the calcium ions are provided by CaCl2. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Regarding claim 4, Abdelsalam teaches a supersaturated solution of Ca2+ comprising about 8 to about 12 mM Ca2+ (Col 29, line 12). Specifically in Example 1 (Col 41), Abdelsalam teaches ELPs (elastin-like polypeptides) coated on glass substrates incubated in a supersaturated solution rich in 10 mM Ca2+. This corresponds to 0.0400 % w/w (i.e. at least 0.001 %).
Regarding claim 5, the rejection is noted above (i.e. at least 0.005 – 1.5 %).
Regarding claim 6, Abdelsalam specifically teaches pentapeptide elastin-line polypeptides Gly-XX-X-X, X-Gly-X-X-X, X-X-Gly-X-X, X-X-X-Gly-X and X-X-X-X-Gly, (GXXXX (SEQ ID NO:3), XGXXX (SEQ ID NO:4), XXGXX (SEQ ID NO:5), XXXGX (SEQ ID NO:6), XXXXG (SEQ ID NO:7) (Col 11, 10th paragraph).
Regarding claim 7, Abdelslam teaches polypeptide substrate thickness can reach up to 1 mm (Fig 1d) in diameter (i.e. 0.5 mm – 1.5 mm).
Regarding claim 8, Abdelsalam teaches that ELP membrane or hydrogel is contacted with a supersaturated solution at or above the inverse transition temperature of the ELP membrane (Col 28, lines 48-50). Here, the supersaturated solution comprises about 8 to about 12 Mm Ca2+ (Col 29, lines 1-2). Abdelsalam discloses that the ELP membrane or solution is formed by dissolving an ELP in solvent (Col 30, lines 1-2) (i.e. ‘a’). Abdelsalam teaches that ELP molecules coated on borosilicate glass upon incubation in a supersaturated solution rich in Ca2+ exhibit hierarchically mineralized structures formed only on ELP membranes, confirming that the ELP sequence, and not the bioactive components, is responsible for the formation of the hierarchically mineralized structures (FIG. 35e-f) (i.e. ‘b’). Also see Col 41, 1st paragraph.
Regarding claim 9, Abdelsalam teaches the ELP concentration in solvent is from about 1 to about 20 % by weight (see Col 30, line 3).
Regarding claim 10, Abdelsalam teaches supersaturated solution rich in 10 mM Ca2+. This corresponds to 0.0400 % w/w (i.e. 0.005 – 1.5 %). See Example 1, Col 41.
Regarding claim 13, Abdelsalam teaches a scaffold membrane, optionally a scaffold membrane with a fabricated topography, is incubated with a mineralizing solution of the invention. The step of incubating comprises nucleation followed by crystal growth (Col 20, 4th paragraph).
Regarding claim 14, Abdelsalam teaches that biomineralization system takes place within the bulk of a transparent ELP membrane (Fig 1b) (See Col 45, 3rd paragraph) (i.e. at least partly inside).
Regarding claim 15, Abdelsalam teaches that control ELP membranes exhibit hierarchical structures but less in number compared to membranes made with the statherin-derived ELP (See Col 45, 3rd paragraph). This hierarchical mineralization can produce membranes that are fully mineralized
not only on the surface but throughout their crosssection (Fig 1f) (i.e. partly on the surface). See Col 45, 4th paragraph, line 12.
Regarding claim 16, Abdelsalam teaches hierarchical structures (See Col 45, 3rd paragraph).
Regarding claim 17, Abdelsalam teaches nanocrystals of on average 85±22 nm thick (Fig 1a).
Regarding claim 18, Abdelsalam teaches nanocrystals organized into circular concentric ring microstructures. (see Fig 23c, Col 50, lines 22-23).
Regarding claim 19, Abdelsalam teaches needle shaped nanocrystals (see claim 3, Fig 3, Fig 35).
Regarding claim 20, Abdelsalam teaches nanocrystal orientation perpendicular to the surface (see Fig 8, Col 41, 3rd paragraph -last 2 lines).
Regarding claim 21, embodiments of the specification disclose ‘flower-like’ as forming prisms or structures similar to the petals of a flower [00145]. Abdelsalam teaches aligned nanocrystals organized in enamel prism-like structures parallel to the surface of the membrane and exhibiting incremental growth lines and an interlocking interface between mineralized structures (See Fig 1g; Col 4-Brief description of figures).
Regarding claim 22, embodiments of the specification disclose fusing can be achieved by mineralizing already mineralized structures (e.g. flower-like) [00150]. Abdelsalam teaches ISE measurements (Fig 13 d) wherein more calcium consumption, faster mineralization, and larger mineralized structures (bottom) up to almost 1 mm in diameter (i.e. fusing).
Regarding claim 23, Abdelsalam teaches SEM images of RGDS-ELP membranes when mineralized without fluoride and the morphology of nanocrystals (see Fig 6 legend; Col 5).
Regarding claim 24, Abdelsalam teaches PO43- and F- in the mineralizing solution (see Col 41, line 8).
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-24 are rejected under 35 U.S.C. 103 as being obvious over Sherif Ahmed Abdelsalam et al., hereinafter Abdelsalam (Sherif Ahmed Abdelsalam et al., US11965016B2, Filed: Jan 31, 2022).
The applied reference has a common Applicant and Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The teachings of Abdelsalam have been set forth above.
Additionally, regarding claim 11, Abdelsalam does not teach a method further comprising cross-linker in a single embodiment.
Abdeldsalam teaches a method comprising contacting an elastin-like polypeptide membrane
or hydrogel with a solution of calcium and phosphate ions in vivo (Col 33, 5th paragraph, lines 1-3). Notably, Abdelsalam teaches that the method further comprises the step of cross-linking. For example, the cross linker may be added after the membrane or hydro gel is added to the solution (and after the mineralizing solution is added, if an exogenous solution is being used) (Col 33, 7th paragraph).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to combine the specific teachings in Abdelsalam to generate a method step further comprising the mixing with a cross-linker, for in vivo application. One motivated to do so would have a reasonable expectation of success as Abdelsalam discloses
the specific method step. Thus, one would have recognized that applying the teaching of Abdelsalam would have yielded predictable results and improved the utility of the composition (See MPEP § 2143 l(A)(D)).
Regarding claim 12, the obviousness rationale has been noted above. Abdelsalam teaches
hexamethyl diisocyanate (HDI). See Example 1, Col 35.
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.
1. Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18,434, 379 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-24 are substantially identical to the claims in the reference application ‘379 and anticipate the instant claims. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
2. Claims 1-7 and 13-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18, 599, 813 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, reference application ‘813 teaches apatite crystalline structures comprising elastin-like polypeptide. Embodiments of the specification in the reference application ‘813 teaches calcium in the crystalline structure (see [0057], Figure 32 legend on page 14).
Regarding claims 2-5, reference application ‘813 teaches a substantially identical composition to the composition instantly claimed. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
Regarding claim 6, reference application ‘813 teaches elastin-like polypeptides. Embodiments of the specification in the reference application ‘813 disclose the polypeptides instantly claimed (see [0077] page 18).
Regarding claim 7, reference application ‘813 teaches crystalline structures. Embodiments of the specification disclose crystalline structures of up to 1 mm diameter [00163].
Regarding claims 13-22, reference application ‘813 teaches crystalline structures that meet the limitations of the instant claims.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/599, 813 (reference application) in view of Sherif Ahmed Abdelsalam et al., hereinafter Abdelsalam (Sherif Ahmed Abdelsalam et al., US11965016B2, Filed: Jan 31, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings in Abdelsalam have been set forth above.
Additionally, regarding claim 8, reference application teaches elastin-like polypeptide composition.
Reference application ‘813 does not teach a process for forming an elastin-like polypeptide membrane.
Abdelsalam teaches the process of forming an elastin-like polypeptide membrane as noted in the rejection under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to combine the specific teachings in Abdelsalam to the teachings in the reference application ‘813, to generate a method steps, for generating polypeptide membrane. Thus, one would have recognized that applying the teaching of Abdelsalam would have yielded predictable results to produce the composition (See MPEP § 2143 l(A)(D)).
Regarding claims 9-12 and 23-24, the obviousness rationale applies in addition to the rejections noted under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) and 35 U.S.C. 103.
3. Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No.11965016. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, reference patent ‘016 teaches crystalline structures comprising elastin-like polypeptides. Embodiments of the specification disclose calcium ions in crystalline structures (see Fig 20 legend; see Col 25, line 17).
Regarding claim 2, the rejection is noted above.
Regarding claim 3, reference patent ‘016 teaches Ca2+ in the embodiments of the specification but does not specifically teach that the calcium ions are provided by CaCl2. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Regarding claim 4, reference patent ‘016 teaches a supersaturated solution of Ca2+ comprising about 8 to about 12 mM Ca2+ (Col 29, line 12). Specifically in Example 1 (Col 41), reference patent ‘016 teaches ELPs (elastin-like polypeptides) coated on glass substrates incubated in a supersaturated solution rich in 10 mM Ca2+. This corresponds to 0.0400 % w/w (i.e. at least 0.001 %).
Regarding claim 5, the rejection is noted above (i.e. at least 0.005 – 1.5 %).
Regarding claim 6, reference patent ‘016 specifically teaches pentapeptide elastin-line polypeptides Gly-XX-X-X, X-Gly-X-X-X, X-X-Gly-X-X, X-X-X-Gly-X and X-X-X-X-Gly, (GXXXX (SEQ ID NO:3), XGXXX (SEQ ID NO:4), XXGXX (SEQ ID NO:5), XXXGX (SEQ ID NO:6), XXXXG (SEQ ID NO:7) (Col 11, 10th paragraph).
Regarding claim 7, reference patent ‘016 teaches polypeptide substrate thickness can reach up to 1 mm (Fig 1d) in diameter (i.e. 0.5 mm – 1.5 mm).
Regarding claim 8, reference patent ‘016 teaches that ELP membrane or hydrogel is contacted with a supersaturated solution at or above the inverse transition temperature of the ELP membrane (Col 28, lines 48-50). Here, the supersaturated solution comprises about 8 to about 12 Mm Ca2+ (Col 29, lines 1-2). Reference patent ‘016 discloses that the ELP membrane or solution is formed by dissolving an ELP in solvent (Col 30, lines 1-2) (i.e. ‘a’). Reference patent ‘016 teaches that ELP molecules coated on borosilicate glass upon incubation in a supersaturated solution rich in Ca2+ exhibit hierarchically mineralized structures formed only on ELP membranes, confirming that the ELP sequence, and not the bioactive components, is responsible for the formation of the hierarchically mineralized structures (FIG. 35e-f) (i.e. ‘b’). Also see Col 41, 1st paragraph.
Regarding claim 9, reference patent ‘016 teaches the ELP concentration in solvent is from about 1 to about 20 % by weight (see Col 30, line 3).
Regarding claim 10, reference patent ‘016 teaches supersaturated solution rich in 10 mM Ca2+. This corresponds to 0.0400 % w/w (i.e. 0.005 – 1.5 %). See Example 1, Col 41.
Regarding claims 11 and 12, reference patent ‘016 teaches cross-linker step See Example 1, Col 35.
Regarding claim 13, reference patent ‘016 teaches a scaffold membrane, optionally a scaffold membrane with a fabricated topography, is incubated with a mineralizing solution of the invention. The step of incubating comprises nucleation followed by crystal growth (Col 20, 4th paragraph).
Regarding claim 14, reference patent ‘016 teaches that biomineralization system takes place within the bulk of a transparent ELP membrane (Fig 1b) (See Col 45, 3rd paragraph) (i.e. at least partly inside).
Regarding claim 15, reference patent ‘016 teaches that control ELP membranes exhibit hierarchical structures but less in number compared to membranes made with the statherin-derived ELP (See Col 45, 3rd paragraph). This hierarchical mineralization can produce membranes that are fully mineralized
not only on the surface but throughout their crosssection (Fig 1f) (i.e. partly on the surface). See Col 45, 4th paragraph, line 12.
Regarding claim 16, reference patent ‘016 teaches hierarchical structures (See Col 45, 3rd paragraph).
Regarding claim 17, reference patent ‘016 teaches nanocrystals of on average 85±22 nm thick (Fig 1a).
Regarding claim 18, reference patent ‘016 teaches nanocrystals organized into circular concentric ring microstructures. (see Fig 23c, Col 50, lines 22-23).
Regarding claim 19, reference patent ‘016 teaches needle shaped nanocrystals (see claim 3, Fig 3, Fig 35).
Regarding claim 20, reference patent ‘016 teaches nanocrystal orientation perpendicular to the surface (see Fig 8, Col 41, 3rd paragraph -last 2 lines).
Regarding claim 21, embodiments of the instant specification disclose ‘flower-like’ as forming prisms or structures similar to the petals of a flower [00145]. Reference patent ‘016 teaches aligned nanocrystals organized in enamel prism-like structures parallel to the surface of the membrane and exhibiting incremental growth lines and an interlocking interface between mineralized structures (See Fig 1g; Col 4-Brief description of figures).
Regarding claim 22, embodiments of the instant specification disclose fusing can be achieved by mineralizing already mineralized structures (e.g. flower-like) [00150]. Reference patent ‘016 teaches ISE measurements (Fig 13 d) wherein more calcium consumption, faster mineralization, and larger mineralized structures (bottom) up to almost 1 mm in diameter (i.e. fusing).
Regarding claim 23, reference patent ‘016 teaches SEM images of RGDS-ELP membranes when mineralized without fluoride and the morphology of nanocrystals (see Fig 6 legend; Col 5).
Regarding claim 24, reference patent ‘016 teaches PO43- and F- in the mineralizing solution (see Col 41, line 8).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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