DETAILED ACTION
Claims 1, 3-6, 8, 10, 12, 14, 16-17, 21-29, 33, 43, 48 and 62-67 are currently pending. Claims 1, 3-5, 10, 12, 17, 21-24, 27-29, 33, 43, 48 and 63-64 are currently under examination.
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 .
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 09/29/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Examiner’s Note
Applicant's amendments and arguments filed 09/29/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 09/29/2025, it is noted that claims 1, 21, 27-29 and 63 are amended and no new matter or claims have been added.
New Objections:
The following new objection are applied based on Applicant’s claim amendments.
Claim Objections
The reply filed on 09/29/2025 is not fully responsive to the prior Office Action because of the following omission(s) or matter(s):
The amendments to the claims do not comply with the Revised Amendment Practice of 37 CFR 1.121 (See OG Notice 23 September 2003). Specifically, a list of all claims should be submitted, the text of withdrawn claims must be included in the listing of the claims and the text of canceled claims must be omitted. Further the claims must have the proper identifiers in parenthetical expression.
The instant claims do not properly recite the claim status identifiers including all withdrawn claims. Claims 6, 8, 14, 16, 25-26, 62 and 65-67 are withdrawn and should be noted as such.
It is noted that 37 CFR 1.121 also states a claim which is previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
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.
Claim(s) 1, 3-5, 10, 12, 17, 22-24, 27-29, 33, 43 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0300428 (previously applied).
Regarding claims 1 and 12, the limitation of an adhesive composition comprising a multivalent metal salt, a pain reliever and a compound of Formula IV (elected phosphoserine), wherein the compound of Formula (IV) is present within the composition in an amount of between 10% and 90% w/w of the total weight of the composition is met by the ‘428 publication teaches composition of use to adhere a variety of materials together (abstract) in the form of an adhesive, self-setting composition [0006]. The composition is taught to include a multivalent metal salt which may be calcium phosphate such as tetra-calcium phosphate [0007]. The adhesive composition includes Formula (IV) which includes phosphoserine ([0035]-[0041]). The composition additionally includes an additive such as a medication that acts as an anesthetic or pain reliever ([0043], [0136]). The compound is taught to be present in the amount of 10% to 90% w/w of the total composition ([0044], [0091], [0134]). The ‘428 publication teaching wherein the aqueous medium is water ([0021], [0096]).
Regarding claims 3-4, the limitation of wherein the multivalent metal salt comprises calcium, tetra-calcium phosphate is met by the ‘428 publication teaching tetra-calcium phosphate [0208].
Regarding claims 5 and 10, the limitation of wherein the composition further comprises a compound of formula III (elected citric acid) is met by the ‘428 publication teaching the composition comprises compound from Formula I, II, III, IV or combinations thereof [0208] such as citric acid (Table 1, III-b and IV-a, [0031]).
Regarding calm 17, the limitation of wherein the aqueous medium is water is met by the ‘428 publication teaching wherein the aqueous medium is water ([0021], [0096]).
Regarding claim 22, the limitation of wherein the adhesive composition has an adhesive strength upon curing of greater than 100 kPa is met by the ‘428 publication teaches the adhesive strength upon curing of greater than 100 kPa [0048].
Regarding claims 23-24, the limitation of further comprising an additive, wherein the additive is a salt (elected) is met by the ‘428 publication teaching mixed salts of several metal ions and combinations of salts ([0091]-[0092]) and wherein additives may include salts (e.g. calcium carbonate, calcium bicarbonate) [0136].
Regarding claim 27-29, the limitation of wherein the multivalent metal salt, the compound of the formula IV and the pain reliever of the adhesive composition are present in the form of powder or granule is met by the ‘428 publication teaching multivalent metal salts is provided as a powder with a mean size of 0.001 to about 1.000 mm, wherein the granule size distribution may be multi-modal and any combination of mean granule sizes [0094]. Compound of Formula IV wherein the powder is 0.001 to about 1.00 mm and may be multimodal to include any combination of mean granule sizes ([0314]-[0135]). Wherein the additives are provided as powders which may be a particle size of about 0.001 to 1.000 mm which may be multi-modal to include any combination of mean granule sizes ([0136]-[0139]). As MPEP 2144.05 recites “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 optimization”.
Regarding claim 33, the limitation of wherein the adhesive composition is porous is met by the ‘428 publication teaches granules may be supplied with a various proportion of porosity and various size of internal pores. The pores may communicate with granule surface or not ([0094], [0135], [0139]).
Regarding claim 43, the limitation of wherein the pain reliever is a NSAID is met by the ‘428 publication teaching nonsteroidal anti-inflammatory drugs [0136].
Regarding claim 48, the limitation of wherein the pain reliever is released from the adhesive composition at a rate determined by the porosity of the composition, a rate at which the composition biodegrades is met by the ‘428 publication teaches additives impart additional functionality to the composition of the disclosure such as resorption rate of the material or provide additional medical properties wherein medications are taught to include NSAID [0136] wherein characteristics which are taught to be improve injectability which include particle size distribution, particle shapes and biodegradability kinetics [0073] wherein the composition is taught to have varying particle sizes ([0094], [0135], [0139]). The drug is taught as being release from the composition [0172]. Thus the ‘428 publication teaches the composition including the claimed ingredients which include an active ingredient and wherein the drug is taught as released and include multiple optimizable parameters such as biodegradability, particle size and resorption rate.
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example tetra-calcium phosphate, pain reliever, phosphoserine, citric acid and salt) from within the prior art disclosure of the ‘428 publication, to arrive at the instantly claimed adhesive composition “yielding no more than one would have expected from such an arrangement”.
Claim(s) 21 and 63-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0300428 as applied to claims 1, 3-5, 10, 12, 17, 22-24, 27-29, 33, 43 and 48 above, and further in view of US 6,713,527 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1, 3-5, 10, 12, 17, 22-24, 27-29, 33, 43 and 48 are taught by the ‘428 publication.
The ‘428 publication does not specifically teach pain reliever is present in an amount from about 0.1 to 40% weight by weight of the total composition (claim 21) wherein the pain reliever is bupivacaine (claims 63-64).
The ‘527 patent teaches surgical bone cement compositions having anesthetic properties and methods for producing analgesia (abstract). The bone cement is taught to have up to about 5% by weight of anesthetic, preferably a local anesthetic (column 2, lines 10-15). The anesthetic is taught to release from the bone cement and be present in an amount of 0.007% to about 5 by weight of said cement composition (column 2, lines 30-40). The anesthetic is taught to include bupivacaine (column 2, lines 35-45). The surgical site of application is taught to be repairing and/or replacing bone and joints (column 5, lines 15-25). The use of anesthetics in bone substitute and calcium phosphate-based cements is considered (column 8, lines 5-15).
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 use bupivacaine in the adhesive composition taught by the ‘428 publication because the ‘428 publication teaches the adhesive composition may include active ingredients such as local anesthetics and the ‘527 patent teaches bupivacaine as a local anesthetic. One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success as the ‘428 publication and the ‘527 patent are both directed to composition that release anesthetics in the treatment of bone wherein both may comprise calcium phosphates. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated to use known specific concentrations and specific anesthetics known to be used in bone treatment as taught by the ‘527 patent in the adhesive composition used to treat bones containing an anesthetic as taught by the ‘428 publication. As MPEP 2144.05 recites “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 optimization”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-4, 12, 17 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/949,382 in view of US 2019/0300428. The instant application and the ‘382 application are directed to adhesive composition which comprise tricalcium phosphate, phosphoserine and water. The phosphoserine is taught to be present between 10 and 90 w/w% of the composition. The instant application differs from the ‘382 application as it includes a pain reliever. The ‘428 publication teaches composition of use to adhere a variety of materials together (abstract) in the form of an adhesive, self-setting composition [0006]. The composition is taught to include a multivalent metal salt which may be calcium phosphate such as tetra-calcium phosphate [0007]. The adhesive composition includes Formula (IV) which includes phosphoserine ([0035]-[0041]). The composition additionally includes an additive such as a medication that acts as an anesthetic or pain reliever ([0043], [0136]). The compound is taught to be present in the amount of 10% to 90% w/w of the total composition ([0044], [0091], [0134]). 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 include a medicament such as a local anesthetic in the composition taught by the ‘382 application as the ‘382 application and the ‘428 publication are both directed to adhesives comprising phosphoserine and calcium phosphate compounds, wherein the ‘428 publication teaches the use of medicaments including local anesthetics was known.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 12, 17 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-13, 15-19 and 23-26 of copending Application No. 17/992,527 in view of US 2019/0300428. The instant application and the ‘382 application are directed to adhesive composition which comprise tricalcium phosphate, phosphoserine and water. The phosphoserine is taught to be present between 10 and 90 w/w% of the composition. The instant application differs from the ‘527 application as it includes a pain reliever. The ‘428 publication teaches composition of use to adhere a variety of materials together (abstract) in the form of an adhesive, self-setting composition [0006]. The composition is taught to include a multivalent metal salt which may be calcium phosphate such as tetra-calcium phosphate [0007]. The adhesive composition includes Formula (IV) which includes phosphoserine ([0035]-[0041]). The composition additionally includes an additive such as a medication that acts as an anesthetic or pain reliever ([0043], [0136]). The compound is taught to be present in the amount of 10% to 90% w/w of the total composition ([0044], [0091], [0134]). 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 include a medicament such as a local anesthetic in the composition taught by the ‘527 application as the ‘527 application and the ‘428 publication are both directed to adhesives comprising phosphoserine and calcium phosphate compounds, wherein the ‘428 publication teaches the use of medicaments including local anesthetics was known.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 12, 17 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-34 of copending Application No. 18/665,143 in view of US 2019/0300428. The instant application and the ‘382 application are directed to adhesive composition which comprise tricalcium phosphate, phosphoserine and water. The phosphoserine is taught to be present between 10 and 90 w/w% of the composition. The instant application differs from the ‘143 application as it includes a pain reliever. The ‘428 publication teaches composition of use to adhere a variety of materials together (abstract) in the form of an adhesive, self-setting composition [0006]. The composition is taught to include a multivalent metal salt which may be calcium phosphate such as tetra-calcium phosphate [0007]. The adhesive composition includes Formula (IV) which includes phosphoserine ([0035]-[0041]). The composition additionally includes an additive such as a medication that acts as an anesthetic or pain reliever ([0043], [0136]). The compound is taught to be present in the amount of 10% to 90% w/w of the total composition ([0044], [0091], [0134]). 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 include a medicament such as a local anesthetic in the composition taught by the ‘143 application as the ‘143 application and the ‘428 publication are both directed to adhesives comprising phosphoserine and calcium phosphate compounds, wherein the ‘428 publication teaches the use of medicaments including local anesthetics was known.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 12, 17 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,247,941 in view of US 2019/0300428. The instant application and the ‘941 patent are directed to adhesive composition which comprise tricalcium phosphate, phosphoserine and water. The phosphoserine is taught to be present between 10 and 90 w/w% of the composition. The instant application differs from the ‘941 patent as it includes a pain reliever. The ‘428 publication teaches composition of use to adhere a variety of materials together (abstract) in the form of an adhesive, self-setting composition [0006]. The composition is taught to include a multivalent metal salt which may be calcium phosphate such as tetra-calcium phosphate [0007]. The adhesive composition includes Formula (IV) which includes phosphoserine ([0035]-[0041]). The composition additionally includes an additive such as a medication that acts as an anesthetic or pain reliever ([0043], [0136]). The compound is taught to be present in the amount of 10% to 90% w/w of the total composition ([0044], [0091], [0134]). 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 include a medicament such as a local anesthetic in the composition taught by the ‘941 patent as the ‘941 patent and the ‘428 publication are both directed to adhesives comprising phosphoserine and calcium phosphate compounds, wherein the ‘428 publication teaches the use of medicaments including local anesthetics was known.
Claims 1, 3-4, 12, 17 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,638,777 in view of US 2019/0300428. The instant application and the ‘777 patent are directed to adhesive composition which comprise tricalcium phosphate, phosphoserine and water. The phosphoserine is taught to be present between 10 and 90 w/w% of the composition. The instant application differs from the ‘777 patent as it includes a pain reliever. The ‘428 publication teaches composition of use to adhere a variety of materials together (abstract) in the form of an adhesive, self-setting composition [0006]. The composition is taught to include a multivalent metal salt which may be calcium phosphate such as tetra-calcium phosphate [0007]. The adhesive composition includes Formula (IV) which includes phosphoserine ([0035]-[0041]). The composition additionally includes an additive such as a medication that acts as an anesthetic or pain reliever ([0043], [0136]). The compound is taught to be present in the amount of 10% to 90% w/w of the total composition ([0044], [0091], [0134]). 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 include a medicament such as a local anesthetic in the composition taught by the ‘777 patent as the ‘777 patent and the ‘428 publication are both directed to adhesives comprising phosphoserine and calcium phosphate compounds, wherein the ‘428 publication teaches the use of medicaments including local anesthetics was known.
Claims 1, 3-4, 12, 17 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,286,102 in view of US 2019/0300428. The instant application and the ‘102 patent are directed to adhesive composition which comprise tricalcium phosphate, phosphoserine and water. The phosphoserine is taught to be present between 10 and 90 w/w% of the composition. The instant application differs from the ‘102 patent as it includes a pain reliever. The ‘428 publication teaches composition of use to adhere a variety of materials together (abstract) in the form of an adhesive, self-setting composition [0006]. The composition is taught to include a multivalent metal salt which may be calcium phosphate such as tetra-calcium phosphate [0007]. The adhesive composition includes Formula (IV) which includes phosphoserine ([0035]-[0041]). The composition additionally includes an additive such as a medication that acts as an anesthetic or pain reliever ([0043], [0136]). The compound is taught to be present in the amount of 10% to 90% w/w of the total composition ([0044], [0091], [0134]). 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 include a medicament such as a local anesthetic in the composition taught by the ‘102 patent as the ‘102 patent and the ‘428 publication are both directed to adhesives comprising phosphoserine and calcium phosphate compounds, wherein the ‘428 publication teaches the use of medicaments including local anesthetics was known.
Claims 1, 3-4, 12, 17 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,178,937 in view of US 2019/0300428. The instant application and the ‘937 patent are directed to adhesive composition which comprise tricalcium phosphate, phosphoserine and water. The phosphoserine is taught to be present between 10 and 90 w/w% of the composition. The instant application differs from the ‘937 patent as it includes a pain reliever. The ‘428 publication teaches composition of use to adhere a variety of materials together (abstract) in the form of an adhesive, self-setting composition [0006]. The composition is taught to include a multivalent metal salt which may be calcium phosphate such as tetra-calcium phosphate [0007]. The adhesive composition includes Formula (IV) which includes phosphoserine ([0035]-[0041]). The composition additionally includes an additive such as a medication that acts as an anesthetic or pain reliever ([0043], [0136]). The compound is taught to be present in the amount of 10% to 90% w/w of the total composition ([0044], [0091], [0134]). 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 include a medicament such as a local anesthetic in the composition taught by the ‘937 patent as the ‘937 patent and the ‘428 publication are both directed to adhesives comprising phosphoserine and calcium phosphate compounds, wherein the ‘428 publication teaches the use of medicaments including local anesthetics was known.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: the ‘428 publication (Hess)
Applicant argues the composition of the ‘428 publication can include an additive which the Office alleges includes the pain reliever presently claimed. The ‘428 publication recites a long list of components that may be used as an additive in its disclosed adhesive composition. Nothing in the ‘428 publication provides any teaching or suggestion much less motivation to develop the adhesive composition with pain relieve recited in the claims.
In response, the ‘428 publication teaches a list of additives which includes medication such as pain reliever. Thus the motivation to include a pain relieve in the composition is present in the ‘428 publication. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example tetra-calcium phosphate, pain reliever, phosphoserine, citric acid and salt) from within the prior art disclosure of the ‘428 publication, to arrive at the instantly claimed adhesive composition “yielding no more than one would have expected from such an arrangement”.
Applicant argues the Office points to no teaching or suggestion much less motivation or evidence to select a pain reliever form the long lists of additives disclosed in the ‘428 publication for producing non-covalently bonded interpenetrating network. It is not enough for a reference to simply list a type of component in a list. Given the myriad of possible options disclosed in the ‘428 publication one of skill in the art would have no reason to select a pain reliever from the options to prepare an adhesive presently claimed or had any reasonable expectation of success.
In response, the ‘428 publication teaches specific types of additives that may be added to the composition including salt, filler, abrasive, coloring agent, flavoring agent or polymer, viscosity modifier or medication, wherein pain relieve is listed as a medication to be used. A person of ordinary skill in the art before the filing date of the claimed invention would easily envision pain reliever being used in the composition as it is selected from a relatively short list of additives as there is a finite listing of possible additives. Thus a prima facie case of obviousness exists. The Examiner is not persuaded that the number of potential combinations is so great that the conclusion of obviousness is called into question. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("[D]isclos[ing] a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art.")."
Applicant argues hindsight.
As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Applicant argues development of an adhesive composition including a pain relievers is highly complex process requiring years of rigorous testing to achieve the desired stability and efficacy results needed in a viable commercial product.
In response, it appears Applicant is arguing unexpected results however has not presented any factual data. Attorney’s arguments may not take the place of factual evidence wherein factual evidence is required.
Double Patenting:
Applicant request the double patenting be held in abeyance until an indication of allowable subject matter is determined.
In response, Applicant has presented no substantive arguments and thus the double patenting rejections are maintained for reasons of record.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613