DETAILED ACTION
Claims 1-6, 10-20, and 28-30 are pending and under consideration on the merits.
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 .
Status of the Rejections
The 35 USC 112(b) rejection is maintained except with respect to claims 7-9 which have been cancelled.
The 103 rejection over Khademosseini in view of Venkatraman et al. (US Pat. Pub. 2016/0331380) is maintained and expanded to include additional claims in view of the amendment, and the remaining 103 rejections are withdrawn in view of the amendment.
The double patenting rejections are maintained and expanded to include the newly added claims.
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.
Claims 2-4, and 5-6, and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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.
Claims 2-3 recites a w/v amount for the gelatin, but they do not specify what it is with respect to, e.g., is it with respect to the total volume of the composition or the total volume of the specifically claimed ingredients? Clarification is required. Dependent claim 4 does not clarify the point of confusion so is also rejected.
Claims 5-6 recite w/v amounts for the nanosilicate, but they do not specify what it is with respect to, e.g., is it with respect to the total volume of the composition or the total volume of the specifically claimed ingredients? Clarification is required.
Claim 10 recites a w/w amount for the radiopaque agent, but does not specify what it is with respect to, e.g., is it with respect to the total weight of the composition or the total weight of the specifically claimed ingredients? Clarification is required.
Response to Applicant’s Arguments
Applicant argues that e.g., claim 2 recites “said hydrogel composition comprises” the recited amount of gelatin, such that the recited range is with respect to the total volume of the hydrogel composition, and that the same is true for the other rejected claims.
In response, the rejected claims comprise more than one ingredient, and additional ingredients also may be present due to the open-ended “comprising” language in the preamble, so the w/v range for gelatin recited by claim 2 could be with respect to a specific ingredient in the hydrogel composition rather than the volume of the overall hydrogel composition. Therefore, the metes and bounds of the rejected claims are unclear unless the claims specifically recite “by total volume of the hydrogel composition” or the like.
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 1-6, 10-20, and 28-30 are rejected under 35 U.S.C. 103 as unpatentable over Khademosseini et al. (US Pat. Pub. 2018/0360920; published 12.20.19; of record in IDS).
As to claims 1-6, 10-20, and 28-30, Khademosseini discloses a shear thinning hydrogel composition comprising gelatin, and silicate nanoparticles (“nanosilicate”)(paragraph 132), wherein the silicate nanoparticles may be a nanoplatelet (paragraph 128) )(claims 1 and 28-30). Khademosseini further discloses shear thinning compositions comprising a radiopaque contrast agent (paragraphs 90, 244).
Regarding claims 2-3, the gelatin may be present in amounts that read on the claimed amounts, such as 6.75 wt% (paragraph 134) and a range of 0.5-20% (paragraph 126).
As to claim 4, the gelatin may be Type A gelatin (paragraph 124).
Regarding claims 5 and 29, the composition may comprise amounts of the silicate nanoparticles that are within the recited range, for example 4.5 wt% (paragraph 134).
Regarding claims 6 and 30, the composition may comprise amounts of the silicate nanoparticles that are encompass the recited amount, e.g., 0.5-10 wt% (paragraph 129).
As to claims 29-30, the composition further may comprise water (paragraph 133).
Regarding claims 13-15 and 18-20, Khademosseini discloses administering the composition to a human (a “mammal”)(paragraph 118) in a method of embolization of a blood vessel (claim 13)(paragraph 116), in a method for reducing blood flow in a blood vessel (claim 14)(paragraph 116), a method for inducing clotting in a blood vessel (claim 15)(paragraph 116), a method of treating a mammal having a bleeding disorder (claim 18)(paragraph 5) such as a saccular aneurysm (claim 19)(paragraph5), and in a method for treating a mammal having a tumor (claim 20)(paragraph 13).
As to claims 1-6, 10-20, and 28-30, Khademosseini does not further expressly disclose a specific embodiment comprising a composition comprising the gelatin, nanosilicate, and radiopaque agent in combination, since paragraph 244 discloses only a shear thinning composition comprising the radiopaque agent and does not specify the other ingredients in the composition. Nor does Khademosseini expressly disclose that the contrast agent is tantalum and in the recited amount of claims 1, 10, and 29-30. Nor does Khademosseini expressly disclose the viscosity of the hydrogel (claim 11) or its displacement pressure (claim 12), the time to clot induction (claim 16), or the volume of the blood clot (claim 17).
Venkatraman discloses hydrogel compositions comprising gelatin and a radiopaque contrast agent such as tantalum (radiopaque marker) (paragraphs 36, 74, 86); wherein the radiopaque marker is in weight range from 5% to about 50%, which overlaps the ranges of claims 1, 10 and 29-30 (para 0107).
As to claims 1-6, 10-20, and 28-31, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Khademosseini composition to comprise the gelatin, nanosilicate, and radiopaque agent in combination, because Khademosseini expressly discloses a “shear thinning” composition comprising a radiopaque contrast agent, and further expressly discloses that the shear thinning compositions taught therein may comprise a gelatin and a nanosilicate, such that the skilled artisan would have recognized that the shear thinning composition comprising a radiopaque contrast agent could comprise a gelatin and a nanosilicate as the other ingredients with a reasonable expectation of success.
It further would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Khademosseini composition to comprise tantalum in the recited amount of claim 1 as the radiopaque agent, because Venkatraman teaches that tantalum is a suitable radiopaque agent for use in gelatin hydrogel compositions, such that the skilled artisan reasonably would have expected that it could serve as the radiopaque agent in the Khademosseini gelatin hydrogel composition, and because the amount is a result effective variable that will affect the ability of the agent to perform its function of enhancing the visibility of internal structures of the body on an x-ray. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The foregoing modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Regarding claim 1, it further would have been prima facie obvious to select an amount of the radiopaque contrast agent that is within the recited range, since said amount is a result effective variable that will affect the ability of the agent to perform its function of enhancing the visibility of internal structures of the body on an x-ray. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The composition of Khademosseini as modified above is viewed as possessing the viscosity of the hydrogel of claim 11 and the displacement pressure of claim 12, and the methods of Khademosseini are viewed as producing the time to clot induction of claim 16 and the volume of the blood clot of claim 17, because Khademosseini teaches a method of administering the same composition comprising the same ingredients recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Response to Applicant’s Arguments
Applicant argues that the cited references do not disclose or suggest that tantalum particles can be combined with silicate nanoplatelets in a single composition.
In response, the cited references must be considered not individually, but rather for what they suggest as a whole. MPEP 2145.IV. Here, Khademosseini teaches hydrogel compositions comprising silicate nanoplatelets, and further teaches embodiments of the hydrogel taught therein that comprise a radiopaque agent, and Venkatraman expressly teaches that tantalum is a known radiopaque contrast agent that is suitable for use in hydrogel compositions, such that the skilled artisan reasonably would have expected that tantalum could be used as the radiopaque contrast agent in the Khademosseini. Such a modification is merely the simple substitution of one known prior art element for another according to known methods to achieve predictable results, which is sufficient to establish a prima facie case of obviousness. MPEP 2143. Applicant has not provided any evidence or articulated reasoning as to why the skilled artisan would not have reasonably expected that tantalum could be used in the Khademosseini hydrogel. Therefore, the rejection is maintained.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 10-20, and 28-30 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 12,318,401, and in view of Khademosseini et al. (US Pat. Pub. 2018/0360920, and Venkatraman et al. (US Pat. Pub. 2016/0331380) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a hydrogel composition comprising 1-5 wt% gelatin and 1-5 wt% silicate nanoparticles, and a method of delivering the composition to a preselected site. Additionally, regarding the amounts of these ingredients, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a radiopaque contrast agent such as tantalum in amounts within the claimed ranges, it would have been prima facie obvious to incorporate same in light of the teachings of Venkatraman that these compounds are useful as contrast agents in gelatin hydrogels in such amounts, and additionally because the amount is a result effective variable that will affect the ability of the agent to perform its function of enhancing the visibility of internal structures of the body on an x-ray. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite that the gelatin is Type A, it would have been prima facie obvious to select this form since Khademosseini teaches that this type of gelatin is suitable for use as a gelling agent in a hydrogel.
Although the reference claims do not specify that the method for delivering to a preselected site is one of the methods recited by claims 13-15 and 18-20, it would have been prima facie obvious to select these methods since Khademosseini teaches that these methods are suitable for administration of a hydrogel comprising gelatin, silicate nanoparticles, and a contrast agent.
Although the reference claims do not specify that the silicate nanoparticles are silicate nanoplatelets, it would have been prima facie obvious to use same because Khademosseini teaches that they are a suitable form of silicate nanoparticles for use in a gelatin hydrogel.
The composition of the reference claims is viewed as possessing the viscosity of the hydrogel of claim 11 and the displacement pressure of claim 12, and the methods of the reference claims as modified above are viewed as producing the time to clot induction of claim 16 and the volume of the blood clot of claim 17, because the reference claims recite a method of administering the same composition comprising the same ingredients recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of 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 as of 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.
Claims 1-6, 10-20, and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 19/198,960, and in view of Khademosseini et al. (US Pat. Pub. 2018/0360920, Venkatraman et al. (US Pat. Pub. 2016/0331380), where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a hydrogel composition comprising 1-5 wt% gelatin and 1-5 wt% silicate nanoparticles, and a method of delivering the composition to a preselected site. Additionally, regarding the amounts of these ingredients, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a radiopaque contrast agent such as tantalum in amounts within the claimed ranges, it would have been prima facie obvious to incorporate same in light of the teachings of Venkatraman that these compounds are useful as contrast agents in gelatin hydrogels in such amounts, and additionally because said amount is a result effective variable that will affect the ability of the agent to perform its function of enhancing the visibility of internal structures of the body on an x-ray. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite that the gelatin is Type A, it would have been prima facie obvious to select this form since Khademosseini teaches that this type of gelatin is suitable for use as a gelling agent in a hydrogel.
Although the reference claims do not specify that the method for delivering to a preselected site is one of the methods recited by claims 13-15 and 18-20, it would have been prima facie obvious to select these methods since Khademosseini teaches that these methods are suitable for administration of a hydrogel comprising gelatin, silicate nanoparticles, and a contrast agent.
Although the reference claims do not specify that the silicate nanoparticles are silicate nanoplatelets, it would have been prima facie obvious to use same because Khademosseini teaches that they are a suitable form of silicate nanoparticles for use in a gelatin hydrogel.
The composition of the reference claims is viewed as possessing the viscosity of the hydrogel of claim 11 and the displacement pressure of claim 12, and the methods of the reference claims as modified above are viewed as producing the time to clot induction of claim 16 and the volume of the blood clot of claim 17, because the reference claims recite a method of administering the same composition comprising the same ingredients recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of 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 as of 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.
Claims 1-6, 10-20, and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 19/029,154, and in view of Khademosseini et al. (US Pat. Pub. 2018/0360920, Venkatraman et al. (US Pat. Pub. 2016/0331380) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a hydrogel composition comprising gelatin and 0.5-4.5 wt% silicate nanoparticles, and a contrast agent, and a method of delivering the composition to treat cancer. Additionally, regarding the amounts of these ingredients, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a radiopaque contrast agent that is tantalum in amounts within the claimed ranges, it would have been prima facie obvious to incorporate same in light of the teachings of Venkatraman that these compounds are useful as contrast agents in gelatin hydrogels in such amounts, and additionally because said amount is a result effective variable that will affect the ability of the agent to perform its function of enhancing the visibility of internal structures of the body on an x-ray. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite that the gelatin is Type A, it would have been prima facie obvious to select this form since Khademosseini teaches that this type of gelatin is suitable for use as a gelling agent in a hydrogel.
Although the reference claims do not specify that the method for delivering the composition is one of the methods recited by claims 13-15 and 18-20, it would have been prima facie obvious to select these methods since Khademosseini teaches that these methods are suitable for administration of a hydrogel comprising gelatin, silicate nanoparticles, and a contrast agent.
Although the reference claims do not specify that the silicate nanoparticles are silicate nanoplatelets, it would have been prima facie obvious to use same because Khademosseini teaches that they are a suitable form of silicate nanoparticles for use in a gelatin hydrogel.
Although the reference claims do not recite the inclusion of water, it would have been prima facie obvious to incorporate water as a carrier since Khademosseini teaches including water as a carrier for hydrogel compositions comprising gelatin, silicate nanoplatelets, and a radiopaque contrast agent.
The composition of the reference claims is viewed as possessing the viscosity of the hydrogel of claim 11 and the displacement pressure of claim 12, and the methods of the reference claims as modified above are viewed as producing the time to clot induction of claim 16 and the volume of the blood clot of claim 17, because the reference claims recite a method of administering the same composition comprising the same ingredients recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of 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 as of 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.
Claims 1-6, 10-12, and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 17/862,959, and in view of Khademosseini et al. (US Pat. Pub. 2018/0360920, Venkatraman et al. (US Pat. Pub. 2016/0331380) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a shear thinning composition comprising 0.5-6.75 wt% gelatin such as Type A gelatin and 1.5-10 wt% wt% silicate nanoparticles, and a contrast agent. Additionally, regarding the amounts of these ingredients, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a radiopaque contrast agent that is tantalum in amounts within the claimed ranges, it would have been prima facie obvious to incorporate same in light of the teachings of Venkatraman that these compounds are useful as contrast agents in gelatin hydrogels in such amounts, and additionally because and additionally because said amount is a result effective variable that will affect the ability of the agent to perform its function of enhancing the visibility of internal structures of the body on an x-ray. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not specify that the silicate nanoparticles are silicate nanoplatelets, it would have been prima facie obvious to use same because Khademosseini teaches that they are a suitable form of silicate nanoparticles for use in a gelatin hydrogel.
Although the reference claims do not recite the inclusion of water, it would have been prima facie obvious to incorporate water as a carrier since Khademosseini teaches including water as a carrier for hydrogel compositions comprising gelatin, silicate nanoplatelets, and a radiopaque contrast agent.
The composition of the reference claims is viewed as possessing the viscosity of the hydrogel of claim 11 and the displacement pressure of claim 12, and the methods of the reference claims as modified above are viewed as producing the time to clot induction of claim 16 and the volume of the blood clot of claim 17, because the reference claims recite a method of administering the same composition comprising the same ingredients recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of 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 as of 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.
Claims 1-6, 10-20, and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 17/956,644, and in view of Khademosseini et al. (US Pat. Pub. 2018/0360920, Venkatraman et al. (US Pat. Pub. 2016/0331380) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a hydrogel composition comprising 1-5 wt% gelatin and 1-5 wt% silicate nanoparticles, and a method of delivering the composition to a preselected site. Additionally, regarding the amounts of these ingredients, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a radiopaque contrast agent such as tantalum in amounts within the claimed ranges, it would have been prima facie obvious to incorporate same in light of the teachings of Venkatraman that these compounds are useful as contrast agents in gelatin hydrogels in such amounts, and additionally because said amount is a result effective variable that will affect the ability of the agent to perform its function of enhancing the visibility of internal structures of the body on an x-ray. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite that the gelatin is Type A, it would have been prima facie obvious to select this form since Khademosseini teaches that this type of gelatin is suitable for use as a gelling agent in a hydrogel.
Although the reference claims do not specify that the method for delivering to a preselected site is one of the methods recited by claims 13-15 and 18-20, it would have been prima facie obvious to select these methods since Khademosseini teaches that these methods are suitable for administration of a hydrogel comprising gelatin, silicate nanoparticles, and a contrast agent.
Although the reference claims do not specify that the silicate nanoparticles are silicate nanoplatelets, it would have been prima facie obvious to use same because Khademosseini teaches that they are a suitable form of silicate nanoparticles for use in a gelatin hydrogel.
Although the reference claims do not recite the inclusion of water, it would have been prima facie obvious to incorporate water as a carrier since Khademosseini teaches including water as a carrier for hydrogel compositions comprising gelatin, silicate nanoplatelets, and a radiopaque contrast agent.
The composition of the reference claims is viewed as possessing the viscosity of the hydrogel of claim 11 and the displacement pressure of claim 12, and the methods of the reference claims as modified above are viewed as producing the time to clot induction of claim 16 and the volume of the blood clot of claim 17, because the reference claims recite a method of administering the same composition comprising the same ingredients recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
Response to Applicant’s Arguments
Applicant argues that the reference claims in combination with the cited secondary references do not disclose or suggest that tantalum particles can be combined with silicate nanoplatelets in a single composition.
In response, the cited references must be considered not individually, but rather for what they suggest as a whole. MPEP 2145.IV. Here, Khademosseini teaches embodiments of the hydrogel taught therein that comprise a radiopaque agent, and Venkatraman expressly teaches that tantalum is a known radiopaque contrast agent that is suitable for use in hydrogel compositions, such that the skilled artisan reasonably would have expected that tantalum could be used as the radiopaque contrast agent in the Khademosseini. Such a modification is merely the simple substitution of one known prior art element for another according to known methods to achieve predictable results, which is sufficient to establish a prima facie case of obviousness. MPEP 2143.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600