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 .
Election/Restrictions
Applicants’ election of Group I (claims 1-20) drawn to a composite material, is acknowledged.
Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03 (a)).
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claims 21-30 are hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction requirement in the reply filed date.
Accordingly, claims 1-20 are under current examination.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See p. 2, line 10). 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.
The use of the term Veriset (see p. 2 and 3), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 3-5, 11-12, 15 and 17 are objected to because of the following informalities:
Claims 3-5, 11 and 17 recite “said association moiety”, whereas claim 1 recites “associating moiety”. As the common term in chemistry is associating moiety, the Examiner suggests amending the terms in claims 3-5, 11 and 17 to “associating moiety” in order to be consistent with the language throughout the claim set.
Claim 12 recites “ε-Lysine” in line 2. The Examiner suggests amending by making the “L” a lowercase “l” as such is not a proper noun and furthermore, consistent with the other species in the claim.
Claim 15 recites multiple values with the unit of measurement micron(s) or millimeter(s). The Examiner suggests amending “10 millimeter” to the plural version as it is over 1: “10 millimeters”; and amending “0.5 microns” to the singular version as it is less than 1: “0.5 micron”.
Appropriate correction is required.
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.
Claims 1-2, 4-5, 10 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yan et al. (CN 101181631; published: 5/21/08).
Yan et al. is directed to a compound prescription for preventing and improving osteosporosis as well as preparation method thereof (Title). Yan et al. teach a composite preparation comprising the following raw materials by weight ratio: 60-180 parts of calcium citrate 60-180 parts of calcium carbonate, 15~45 parts of magnesium citrate, 3~9 parts of zinc citrate, 15~45 parts of collagen, vitamin D3, 2-6 parts of auxiliary materials, 8~23 parts (limitations of instant claims 1-2, 4-5, 10, 16; See Summary of the Invention – p. 2). With respect to the claim 1 limitation wherein the associating moiety (in this case, collagen) being associated with (i.e., forming electrostatic interactions with) said citrate and said calcium carbonate-containing material, since the composition taught by Yan et al. comprises the same compounds (i.e., citrate, calcium carbonate and collagen), the same electrostatic interactions must necessarily be present.
Therefore, by teaching all the limitations of claims 1-2, 4-5, 10 and 16, Yan et al. anticipate the instant invention 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baranes et al. (WO 2017/046809; published: 3/23/17), in view of Yuki et al. (US 2020/0009290; published: 1/9/20).
Claims 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baranes et al. (US 10,695,364; US effective filing date: 9/20/16), in view of Yuki et al. (US 2020/0009290; published: 1/9/20).
Examiner’s Note: Baranes et al. (WO 2017/046809) is 102(a)(1) prior art and Baranes et al. (US 10,695,364) is 102(a)(2) prior art. The disclosures of ‘809 and ‘364 are identical and therefore the rejection is also identical and all citations below are in reference to WO 2017/046809.
The applied reference (US 10,695,364) has a common inventor (Baranes) 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.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Baranes et al. is directed to anti-hemorrhaging compositions (Title).
With regards to instant claim 1, Baranes et al. teach a composition comprising a citrate salt and a calcium carbonate-containing material (Abstract).
With regards to instant claim 13, Baranes et al. teach wherein the calcium carbonate-containing material comprises amorphous calcium carbonate (p. 4, lines 9-10).
With regards to instant claim 14, Baranes et al. teach wherein the calcium carbonate-containing material is a particulate material (p. 4, lines 11-12).
With regards to instant claim 15, Baranes et al. teach wherein the particulate material comprises particles having an average particle diameter in the range of from 0.1 micron to 10 millimeters, or from 0.1 micron to 1 millimeter, or from 0.1 micron to 500 microns, or from 0.5 microns to 500 microns, or from 1 micron to 500 microns, or from 5.0 microns to 500 microns (p. 4, lines 13-17).
With regards to instant claim 16, Baranes et al. teach a weight ratio of the citrate and the calcium carbonate-containing material ranges from 10:1 to 1:300 (p. 4, lines 18-19). As indicated in MPEP §2144.05(I): “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
With regards to instant claim 18, Baranes et al. teach wherein other anti-coagulants can be used as alternative, or in addition, to a citrate salt as described herein (p. 14, lines 14-19).
With regards to instant claim 19-20, Baranes et al. teach that the compositions formulated in a compatible pharmaceutical carrier may also be prepared (p. 16, lines 31-32). Baranes et al. teach wherein the composition is formulated as a topical dosage form). Baranes et al. teach wherein the composition is formulated as a topical dosage form (p. 4, lines 20-21).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Baranes et al. do not teach, wherein the abovementioned composition further comprises an associating moiety being associated with said citrate and said calcium carbonate-containing material, as required by instant claim 1. And furthermore, Baranes et al. do not teach wherein such associating moiety is poly-L-lysine (i.e., a positively charged moiety at physiological pH, a polymeric moiety, a biocompatible moiety, a polypeptide, a polypeptide that comprises or consists essentially of at least one amino acid residue that is positively charged at physiological pH), as required by instant claims 2-9 and 11-12. However, this deficiency is cured by Yuki et al.
Yuki et al. is directed to liquid embolic agent composition (Title). Yuki et al. teach that its composition comprises a coagulation promoting component such as poly-L-lysine hydrobromide ([0015). Yuki et al. also teach that the positively charged poly-L-lysine hydrobromide coexist in the composition with an acidic polysaccharide and they form a complex due to electrostatic interactions ([0029]). It is noted that Baranes et al. teach that while further exploring the effect of exposing blood to calcium carbonate, the present inventors have uncovered, by serendipity, that when a calcium carbonate-containing material is contacted with blood in the presence of a citrate salt, induction of blood coagulation is effected (p. 7, lines 13-16).
Baranes et al. and Yuki et al. do not specifically teach wherein the weight ratio of the associating moiety (e.g., poly-L-lysine) and calcium carbonate-containing material (e.g., amorphous calcium carbonate) ranges from 5000:1 to 250:1, as required by instant claim 17.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional coagulation promoting agents (citrate + calcium carbonate-containing material taught by Baranes et al. and poly-L-lysine taught by Yuki et al.) used in formulations used to induce blood coagulation. It would follow that the recited claims define prima facie obvious subject matter. (See MPEP 2144.06).
Examiner’s note: With respect to the claim 1 limitation wherein the associating moiety (in this case, poly-L-lysine) being associated with (i.e., forming electrostatic interactions with) said citrate and said calcium carbonate-containing material, since the composition taught by Baranes et al. and Yuki et al. comprises the same compounds (i.e., citrate, calcium carbonate and poly-L-lysine), the same electrostatic interactions must necessarily be present. Such is also evident by the teaching from Yuki et al.: the positively charged poly-L-lysine hydrobromide coexist in the composition with an acidic polysaccharide and they form a complex due to electrostatic interactions ([0029]).
The weight ratio of poly-L-lysine and calcium carbonate in the coagulation promoting composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount an active agent (and its ratios within the composition) in order to best achieve the desired results as such would provide advantageous biological effect. 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 engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Baranes et al. teach that in its compositions when a calcium carbonate-containing material is combined with a citrate salt and contacted with blood, induction of blood coagulation is effected (p. 7, lines 13-16 ). Yuki et al. teach that its composition comprises a coagulation promoting component such as poly-L-lysine hydrobromide ([0015). The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amounts of poly-L-lysine and calcium carbonate would impact the efficacy in the treatment of a hemorrhage and therefore be an optimizable variable.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 1-7, 10, 13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baranes et al. (WO 2017/046809; published: 3/23/17), in view of Connolly et al. (US 2016/0278785; published: 9/29/16).
Alternatively, claims 1-7, 10, 13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baranes et al. (US 10,695,364; US effective filing date: 9/20/16), in view of Connolly et al. (US 2016/0278785; published: 9/29/16).
Examiner’s Note: Baranes et al. (WO 2017/046809) is 102(a)(1) prior art and Baranes et al. (US 10,695,364) is 102(a)(2) prior art. The disclosures of ‘809 and ‘364 are identical and therefore the rejection is also identical and all citations below are in reference to WO 2017/046809.
The applied reference (US 10,695,364) has a common inventor (Baranes) 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.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Baranes et al. is directed to anti-hemorrhaging compositions (Title).
With regards to instant claim 1, Baranes et al. teach a composition comprising a citrate salt and a calcium carbonate-containing material (Abstract).
With regards to instant claim 13, Baranes et al. teach wherein the calcium carbonate-containing material comprises amorphous calcium carbonate (p. 4, lines 9-10).
With regards to instant claim 14, Baranes et al. teach wherein the calcium carbonate-containing material is a particulate material (p. 4, lines 11-12).
With regards to instant claim 15, Baranes et al. teach wherein the particulate material comprises particles having an average particle diameter in the range of from 0.1 micron to 10 millimeters, or from 0.1 micron to 1 millimeter, or from 0.1 micron to 500 microns, or from 0.5 microns to 500 microns, or from 1 micron to 500 microns, or from 5.0 microns to 500 microns (p. 4, lines 13-17).
With regards to instant claim 16, Baranes et al. teach a weight ratio of the citrate and the calcium carbonate-containing material ranges from 10:1 to 1:300 (p. 4, lines 18-19). As indicated in MPEP §2144.05(I): “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
With regards to instant claim 18, Baranes et al. teach wherein other anti-coagulants can be used as alternative, or in addition, to a citrate salt as described herein (p. 14, lines 14-19).
With regards to instant claim 19-20, Baranes et al. teach that the compositions formulated in a compatible pharmaceutical carrier may also be prepared (p. 16, lines 31-32). Baranes et al. teach wherein the composition is formulated as a topical dosage form (p. 4, lines 20-21).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Baranes et al. do not teach, wherein the abovementioned composition further comprises an associating moiety being associated with said citrate and said calcium carbonate-containing material, as required by instant claim 1. And furthermore, Baranes et al. do not teach wherein such associating moiety is collagen (i.e., a positively charged moiety at physiological pH, a polymeric moiety, a biocompatible moiety, a polypeptide, a polypeptide that comprises or consists essentially of at least one amino acid residue that is positively charged at physiological pH), as required by instant claims 2-7 and 10. However, this deficiency is cured by Connolly et al.
Connolly et al. is directed to biologic-based expandable occlusion device, that once implanted, the biologic layer acts to slow or halt the blood flow, and the entire device may act as a substrate for coagulation and tissue ingrowth, creating a permanent embolus if desired (Title, [0081]). Connolly et al. teach that collagens have a triple helix motif composed of three chains, each of which comprises an amino acid sequence in which glycine (Gly) is typically present as every third residue (e.g., Gly-X-Y, where X and Y are variable and are often Pro or Hyp (hydroxyproline)) ([0042]). Connolly et al. also teach that it is well known that collagen is highly thrombogenic, leading to quick clot formation ([0046]). It is noted that Baranes et al. teach that while further exploring the effect of exposing blood to calcium carbonate, the present inventors have uncovered, by serendipity, that when a calcium carbonate-containing material is contacted with blood in the presence of a citrate salt, induction of blood coagulation is effected (p. 7, lines 13-16).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional coagulation promoting agents (citrate + calcium carbonate-containing material taught by Baranes et al. and collagen taught by Connolly et al.) used in formulations used to induce blood coagulation (i.e., blood clots). It would follow that the recited claims define prima facie obvious subject matter. (See MPEP 2144.06).
Examiner’s note: With respect to the claim 1 limitation wherein the associating moiety (in this case, collagen) being associated with (i.e., forming electrostatic interactions with) said citrate and said calcium carbonate-containing material, since the composition taught by Baranes et al. and Connolly et al. comprises the same compounds (i.e., citrate, calcium carbonate and collagen), the same electrostatic interactions must necessarily be present.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
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 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 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 8, 12, 16-18, 23 and 25-40 of copending Application No. 18/689,875.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising a citrate, a calcium-carbonate containing material (e.g., amorphous calcium carbonate and/or particulate material) and an associating moiety (e.g., poly-L-lysine or collagen) and optionally further comprising a swelling polymeric moiety, all with particular weight ratios and particle sizes. The ‘875 claims are directed to the method of using the abovementioned composition, whereas the instant claims are directed to the composition. The difference is that the ‘875 method is directed to treating a chronic wound, a non-bleeding wound or treating or preventing an inflammatory pain or nociceptive pain by administering to the subject in an effective amount of abovementioned composition. However, one of ordinary skill in the art would recognize that if he/she knew how to use the instantly claimed composition (method of ‘875), then it is obvious that the instant composition was known at the time of filing. Thus, the instant claims and the application claims are obvious variants.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 directed to an invention not patentably distinct from claims 1, 8, 12, 16-18, 23 and 25-40 ated of commonly assigned 18/689,875. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/689,875, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,695,364, in view of Connolly et al. (US 2016/0278785; published: 9/29/16) and Yuki et al. (US 2020/0009290; published: 1/9/20). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With regards to ‘364 claims 1-17: both claim sets are drawn to the same composition comprising a citrate and a calcium-carbonate containing material (e.g., amorphous calcium carbonate and/or particulate material), all with particular weight ratios and particle sizes. It is noted that the ‘364 composition represents a species (with regards to (1) the type of calcium carbonate-containing material such as crystalline calcium carbonate, coral exoskeleton, acellular coral exoskeleton, aragonite, biogenic aragonite, geological aragonite; (2) the form of the topical composition such as powder, a gel, a spray, a foam, a mousse, an ointment, a paste, a lotion, a gauze, a wound dressing, a suspension, an adhesive bandage, a non-adhesive bandage, a wipe, a gauze, a pad, and a sponge; (3) an article-of-manufacturing or a kit comprising the abovementioned composition) within the scope of the instantly claimed genus. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cor. 1993). Thus, the instant claims and the application claims are obvious variants.
With regards to ‘364 claims 18-25: both claim sets are drawn to the same composition comprising a citrate, a calcium-carbonate containing material (e.g., amorphous calcium carbonate and/or particulate material), all with particular weight ratios and particle sizes. The ‘364 claims are directed to the method of using the abovementioned composition, whereas the instant claims are directed to the composition. The difference is that the ‘364 method is directed to inducing coagulation of blood or reducing or arresting hemorrhaging in a subject in need thereof by contacting the blood with the abovementioned composition. However, one of ordinary skill in the art would recognize that if he/she knew how to use the instantly claimed composition (method of ‘875), then it is obvious that the instant composition was known at the time of filing. Thus, the instant claims and the application claims are obvious variants.
With regards to ‘364 claims 1-25: another difference is that the ‘364 claims do not require the addition of an associating moiety (e.g., poly-L-lysine or collagen), which is required by the instant claims. However, it is known in the art that poly-L-lysine or collagen are used in formulations to induce blood coagulation and therefore it would have been obvious to combine the claimed citrate + calcium carbonate-containing material combination that induces blood coagulation with other ingredients that are used by the same purpose (See MPEP 2144.06). Thus, the instant claims and the application claims are obvious variants.
Claims 1-20 are directed to an invention not patentably distinct from claims 1-25 of commonly assigned U.S. Patent No. 10,695,364. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 10,695,364, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617