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 .
Claim Status
Applicants’ response of April 28, 2025, to the non-final action mailed January 30. 2025, has been entered. Claims 14 and 16 have been amended, claims 2, 7, 15, and 17-20 have been cancelled, and claims 23-26 have been added. Accordingly, claims 1, 3-6, 8-14, 16, and 21-26 are pending and under current examination.
Information Disclosure Statement
The Japanese’s Office Action for Appl. No. 2021-566068 filed with the information disclosure statement on March 25, 2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
NEW - Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
37 CFR 1.118(a) states “No amendment shall introduce new matter into the disclosure of an application after the filing date of the application”. In the instant case, the recitation of limitation “wherein the collagen is in powdered from.” (Claims 25 and 26) is considered new matter. In the response of April 28, 2025 Applicant did not disclose wherein the specification this limitation was found. Upon review of the instant specification, examiner could only find support for the composition as a whole being in powdered form ([0012] and Table 1). The Examiner could not find support for the term the separate component of collagen being in powdered form.
Thus, at the time the application was filed, an Artisan of skill would not recognize from the disclosure that Applicant was in possession of the individual component of collagen being in powdered form as claimed.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph-written description requirement”. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981) teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed…If a claim is amended to include subject matter, limitation or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes, “When an amendment is filed in reply to an objection or rejection based on U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendment made to the disclosure”.. This is a new matter rejection.
Withdrawn Claim Objection
Claims 14 and 16 were objected in the previous Office action mailed January 30. 2025, for missing periods at the end of the claims. Additionally, these are claims that do not have to be provided in tabular format in the claim. Applicant has amended the claims to correct for the deficiencies. Accordingly, the objection is hereby withdrawn.
Response & Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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, 3-6, 8-14, 16 and 21-22 remain rejected and claims 23-24 are newly rejected under 35 U.S.C. 103 as being unpatentable over Edward Walker (US20090258833A1, publication date: 10/15/2009, previously cited) (Hereinafter Walker) and Matthew Hesse et al (WO2016112170A1, publication date: 07/14/2016, previously cited) (Hereinafter Hesse) as evidenced by Collagen vs Collagen Peptides: Complete Guide: (Wellbeing Nutrition: Pub. Date: 12-23-2025. https://wellbeingnutrition.com/blogs/skin-beauty/collagen-vs-collagen-peptides-complete-guide?srsltid=AfmBOor4d8px3EjhsMptqpInCHactlfCYetHkKF-e-mbevmZW1XANizI) for reasons of record. Applicant’s amendment of adding claims 23-24 necessitate the additional new rejections.
Applicant previously amended claim 1 by replacing "comprises" language with "consists of" in the preamble. Applicant previously amended claim 1 to require "valine, lysine, phenylalanine, threonine, tryptophan, histidine, and methionine" as well as the limitation of "total sugar in an amount no greater than 4g per serving." Applicant previously amended claim 16 similarly, the difference being instant claim 16 additionally requiring "about 15-26 grams of collagen" and "0.1-0.2 grams of taurine".
Regarding claim 1, The preamble of “a dietary supplement” is interpreted as intended use and does not constitute a functional limitation. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02 II. Walker teaches a “liquid protein supplement” (interpreted as ready to drink liquid) comprising: a liquid solution including, a hydrolyzed liquid collagen; supplemental sulfur containing amino acids in an amount sufficient to give the liquid solution a weight percent of sulfur containing amino acids of at least about 0.75% (w/w), based on total protein content in the liquid solution; and optionally taurine.” (claim 1). Thus, since Walker only requires collagen, sulfur containing amino acid (such as methionine), the instantly claimed “consisting of” language is met. Walker also teaches “hydrolyzed liquid collagen”, “taurine” and “glutamine” (para 37-38, table 1). Regarding the instantly claimed serving amount of 24 fluid ounces, Walker teaches “In one embodiment the volume of a dose of the composition is in a range from about 0.5 fluid ounce to about 30 ounces” (para 33). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I. The instantly claimed serving size (dose) of 24 ounces is within the 0.5-30 ounces range taught by Walker. Regarding the instantly claimed amounts of 15-25 grams per serving, 0.5-1.5 grams per serving and 0.1-0.2 grams per serving for collagen, glutamine and taurine respectively, since instant claim teaches a total of 36-38 grams of serving, in effect, the instant claim claims about 39-69 wt % of collagen, about 1-4 wt % of glutamine and 0.2-0.6 wt % of taurine. Walker teaches “at least about 35 wt % of the hydrolyzed liquid collagen, based on the total weight of the liquid solution” (claim 9). Walker also teaches “the weight percent of collagen of the total protein content of the liquid solution is at least about 40%” (para 22). Walker also teaches- “the fortified protein compositions can include taurine in a concentration range of 0.5-10% of the total protein present” (para 28). The instantly claimed range for collagen is within the range taught by Walker, and the instantly claimed range for taurine overlaps with the range taught by Walker. Regarding the instantly claimed glutamine amount, Walker teaches glutamine (table 1), and the concentration of glutamine taught by Walker, which is about 0.4% (2.1/482.6) (table 1). Walker also teaches each of the instantly claimed amino acids (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) (table 1). Regarding the instantly claimed “optionally at least one additional ingredient selected from the group consisting of carbohydrate, protein, vitamins, electrolytes, minerals, flavors, colors, coconut water powder, malic acid, fruit extract and combinations thereof,” it is noted that these are optional and need not be met by Walker. For the purposes of compact prosecution, Walker teaches “further comprising a sweetener and a flavoring” (claim 12), “colorings” (para 30). Regarding the instantly claimed “total sugar in an amount no greater than 4g per serving,” it is noted that claim 1 of Walker does not require any amount of sugar and thus a person of ordinary skill in the art would achieve a composition with total sugar in an amount no greater than 4g per serving. That said, Walker also teaches “sugar free liquid protein supplement” (para 37, para 40, para 41).
Regarding claim 3, Walker teaches amino acids to be soluble powder which can be mixed into liquid composition (para 23).
Regarding claim 4, Walker teaches as discussed above.
Regarding claim 5, regarding the instantly claimed amounts of 17-23 grams per serving, 0.75-1.25 grams per serving and 0.125-0.175 grams per serving for collagen, glutamine and taurine respectively, since instant claim teaches a total of 36-38 grams of serving, in effect, the instant claim claims about 45-64 wt % of collagen, about 2-3 wt % of glutamine and 0.3-0.5 wt % of taurine. As discussed above, the instantly claimed range for collagen is within the range taught by Walker, and the instantly claimed range for taurine overlaps with the range taught by Walker. Walker also meets the instantly claimed glutamine amount for the reasons discussed above.
Regarding claim 6, regarding the instantly claimed amounts of 20 grams per serving, 0.97 grams per serving and 0.135 grams per serving for collagen, glutamine and taurine respectively, since instant claim teaches a total of 36-38 grams of serving, in effect, the instant claim claims about 53-56 wt % of collagen, about 3 wt % of glutamine and about 0.4 wt % of taurine. As discussed above, the instantly claimed range for collagen is within the range taught by Walker, and the instantly claimed range for taurine overlaps with the range taught by Walker. Walker also meets the instantly claimed glutamine amount for the reasons discussed above.
Regarding claim 8, since coconut water powder is optional, the limitations of instant claim need not be met by Walker.
Regarding claim 9, since electrolytes are optional, the limitations of instant claim need not be met by Walker.
Regarding claim 12, since minerals are optional, the limitations of instant claim need not be met by Walker.
Regarding claims 10-11, Walker teaches each of the nine essential amino acids (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) as discussed above. Regarding the instantly claimed amounts of 6-10 grams (for claim 9) and 8 grams (for claim 10), the instant claims claim about 16-28 wt % and about 21-22 wt % for claims 10 and 11 respectively. Walker teaches tryptophan from about 0.5-10 wt % (para 29), methionine from at least about 2 wt % (para 26). For the remaining amino acids, Walker teaches histidine at about 1 wt % (table 1), isoleucine at about 1 wt % (table 1), leucine at about 3 wt % (table 1), lysine at about 3 wt % (table 1), phenylalanine at about 2 wt % (table 1), threonine at about 3 wt % (table 1), valine at about 2 wt % (table 1). In table 1, Walker also teaches tryptophan at about 1 wt % and methionine at about 1 wt %. Thus the we % content of all essential amino acids taught by Walker in table 1 is 17 wt % which is within the range claimed in claim 10. A specific example in the prior art which is within a claimed range anticipates the range. MPEP 2131.03. 17 wt % taught by Walker is within the 16-28 wt % range of instant claim 10. Regarding the 21-22 wt % range of instant claim 11, as discussed above, Walker teaches increased amounts of tryptophan and methionine beyond what is taught in table 1 resulting in a range of at least 17 wt % of essential amino acids. Thus, the instantly claimed range of 21-22 wt % is within the range taught by Walker.
Regarding claim 14, Walker teaches every single instantly claimed amino acid (table 1 of Walker). Regarding the instantly claimed amounts, which are about (calculated based on 37 g of serving) 5 wt % for alanine, 4 wt % for arginine, about 3 wt % for aspartic acid, about 8 wt % for glutamic acid, about 13 wt % for glycine, about 0.4 wt % for histidine, about 0.1 wt % for hydroxylysine, about 6 wt % for hydroxyproline, about 3 wt % for isoleucine, about 8 wt % for leucine, about 4 wt % for lysine, about 0.4 wt % for methionine, about 3 wt % for phenylalanine, about 7 wt % for proline, about 2 wt % for serine, about 2 wt % for threonine, about 0.2 wt % for tryptophan, about 0.3 wt % for tyrosine and about 4 wt % for valine. Walker teaches about 1 wt % for alanine, 7.2 wt % for arginine, about 5 wt % for aspartic acid, about 9 wt % for glutamic acid, about 21 wt % for glycine, about 1 wt % for histidine, about 0.6 wt % for hydroxylysine, about 10 wt % for hydroxyproline, about 1 wt % for isoleucine, about 3 wt % for leucine, about 3 wt % for lysine, about 1 wt % for methionine, about 2 wt % for phenylalanine, about 12 wt % for proline, about 3 wt % for serine, about 3 wt % for threonine, about 0.7 wt % for tryptophan, about 0.2 wt % for tyrosine and about 2 wt % for valine. Additionally, regarding tryptophan and methionine, Walker teaches broader ranges which are discussed above. Additionally, Walker teaches varying the amount of collagen which is discussed above. By varying the amount of collagen, relative amounts taught by Walker would change according to the total amount of collagen present in the composition. Thus, absent evidence of criticality for the instantly claimed amounts, there is a prima facie case of obviousness. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since, Walker teaches varying the relative amount of collagen and other amino acids, as discussed above, a person of ordinary skill in the art would achieve the instantly disclosed concentration ranges via routine optimization.
Regarding claim 16, Walker teaches as discussed above.
Regarding claims 8 and 13, Walker does not teach powdered coconut water or vitamins.
Regarding claims 21-22, Walker does not teach the instantly claimed glutamine amount to be from about 2 to 3.5 weight percent of the composition.
Regarding claims 1 and 21-22, Hesse teaches glutamine between 0-25 % (para 72, table A). The instantly claimed ranges of about 1-4% and about 2-3.5% by weight for glutamine are within the range taught by Hesse.
Regarding claim 8, Hesse provides for a powder soluble in a liquid medium to make a liquid (abstract) and teaches “a performance enhancing composition” (claim 1) comprising “at least one performance enhancing component selected from the group consisting of leucine, isoleucine, valine, betaine anhydrous, citrulline, glutamine, and branched chain ammo acids, coconut water powder . . .” (para 10). Regarding the instantly claimed 10-20 wt % range for the coconut water powder, Hesse teaches “the at least one performance enhancing component of the immediate release powder is optionally present at a weight percent of the performance enhancing immediate and extended release powder blend of about 5% to about 50%, or any value or range therebetween. For example, the at least one performance enhancing component of the immediate release powder is optionally present at a weight percent of . . . about 10% to about 15%, about 15% to about 20% . . .” (para 25).
Regarding claim 13, Hesse teaches a vitamin (claim 12) and also teaches “A performance enhancing component is intended to encompass one or more of a: vitamin (e.g. vitamin B12 (optionally in the form of methycobalamin available from Anmar), vitamin B3 (optionally in the form of nicinaminde/nicotinamide available from DSM) among others)” (para 21).
For the purposes of compact prosecution, Hesse also teaches glutamine between 0-25 % (para 72, table A). branched chain amino acids (BCAA) (para 72 table A), leucine between 0-60%, isoleucine 0-25%, valine 0-25% (para 72 table A). Hesse also teaches a method of administration (para 61) “As such processes are provided for enhancing athletic performance or preventing fatigue that include administering a the instantly-disclosed composition(s) as provided to a mammalian subject, optionally a human, wherein the administration is performed at a time suitable for enhancing athletic performance or preventing fatigue. Thus, processes are provided for maintaining vasodilation during and after a workout, stimulating muscle synthesis and repair over an extending period of lime, and/or preventing athletic fatigue, such as sustaining energy levels and avoiding a subsequent energy level crash, that include administering the instantly-disclosed immediate and extended release performance enhancing supplement compositions” (para 61).
Regarding claims 23 and 24, Walker discloses hydrolyzed collagen ([0021] and [0022]), hydrolysis is the practice of practice of breaking the bonds of collagen proteins ([0008] and [0021]), hydrolyzed collagen is collagen in the form of collagen peptides as evidenced by Collagen vs Collagen Peptides: Complete Guide: Section Wat are Collagen Peptides: The Bioavailable Solution).
Regarding claims 25 and 26, Walker discloses hydrolyzed collagen is the major percentage of the oval weight of the protein ([0022] and [0022]), hydrolysis is the practice of practice of breaking the bonds of collagen proteins ([0008] and [0021]), hydrolyzed collagen is collagen in the form of collagen peptides as evidenced by Collagen vs Collagen Peptides: Complete Guide: Section Wat are Collagen Peptides: The Bioavailable Solution
It would have been obvious to one of ordinary skill in the art at the time of instant application to have combined the teachings of Walker and Hesse and achieve the instant invention. Addition of coconut water powder and/or vitamins to a dietary supplement formulation is an obvious modification to the compositions taught by Walker. A person of ordinary skill in the art would merely be combining prior art elements according to known methods to yield predictable results. Hesse evidences that addition of said compounds to a supplement formulation is a known and predictable modification. Thus, absent evidence of unexpected results for the addition of these compounds, there is a prima facie case of obviousness established.
Claims 1, 9 and 12 remain rejected under 35 U.S.C. 103 as being unpatentable over Edward Walker (US20090258833A1, publication date: 10/15/2009, previously cited) (Hereinafter Walker), Matthew Hesse et al (WO2016112170A1, publication date: 07/14/2016, previously cited) (Hereinafter Hesse), and Christine L. Clinger et al (US20090162518A1, publication date: 06/25/2009, previously cited) (Hereinafter Clinger) for reasons of record.
Regarding claim 1, Walker and Hesse teach as discussed above.
Regarding claim 9, Walker does not teach electrolytes.
Regarding claim 12, Walker does not teach selenium.
Regarding claims 9 and 12, Clinger teaches nutritional powders (para 3) comprising “sufficient protein, carbohydrate, lipid, vitamins, minerals, and electrolytes” (para 14) and “The embodiments herein may comprise any of a variety of minerals, non-limiting examples of which include calcium, phosphorus, magnesium, iron, zinc, manganese, copper, iodine, sodium, potassium, molybdenum, chloride, selenium, chromium, chloride, salts and derivatives thereof, and combinations thereof” (para 49).
It would have been obvious to one of ordinary skill in the art at the time of instant application to have combined the teachings of Walker, Hesse and Clinger and achieve the instant invention. Addition of minerals such as selenium and electrolytes to a dietary supplement formulation is an obvious modification to the compositions taught by Walker. A person of ordinary skill in the art would merely be combining prior art elements according to known methods to yield predictable results. Clinger evidences that addition of said compounds to a supplement formulation is a known and predictable modification. Thus, absent evidence of unexpected results for the addition of these compounds, there is a prima facie case of obviousness established. Additionally, Clinger also provides the motivation of “A novel nutritional powder having improved oxidative stability and sensory performance” (para 6), thus one would be motivated to incorporate the teachings of Clinger into the teachings of Walker with a reasonable expectation of success.
New Claim Rejections - 35 USC § 103
Claim(s) 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Edward Walker (US20090258833A1, publication date: 10/15/2009, previously cited) (Hereinafter Walker) and Matthew Hesse et al (WO2016112170A1, publication date: 07/14/2016, previously cited) (Hereinafter Hesse) as applied to claims 1 and 16 above, and further in view of Koitel (Pub No.: WO 2016/113613; Pub. Date July 21, 2016).
Regarding claims 25 and 16 Walker and Hesse et al. remains as applied to claims 1 and 16 as fully set forth above. While the combination of references teaches a composition for consumption comprising collagen as fully set for the above. The combination does not explicitly teach that the collagen before mixed in a liquid is in powdered form.
However, in the same field of endeavor of compositions comprising collagen to be consumed, Koitel discloses that the collagen prior to being added to water is in powder form (page 25 lines 8-12)
It would have been prima facie obvious to one of ordinary skill in the art at the time of instant application to have combined the teachings of Walker, Hesse and Koitel for the collagen to be in powdered form as disclosed by Koitel in a composition meant to be consumed. One of ordinary skill would be motivated to have the collagen in powdered formas a matter of design choice in order to achiever unform wetting with a liquid as disclosed by Koitel (page 10 lines 9-10) with a reasonable expectation of success, at the time of the invention. Said design choice amounting to combining prior art elements according to a known method to yeild predictable results. it would only require routine experimentation to modify the method of Walker to have collagen in powder form before mixing with liquid as required by the claimed invention.
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art at the time of filing.
Response to Arguments
Applicant’s Remarks filed on 4/28/26 have been received and entered. Applicant traverses the 103 type rejections arguing:
Walker does not disclose or suggest a dietary supplement composition consisting of the instantly claimed features. Walter requires “at least hydrolyzed collagen and a supplemental protein containing sulfur containing two sulfur containing amino acids methionine and cystine. There would be no motivation to remove the cysteine.
Applicant’s argument has been fully considered, but not found persuasive. In paragraph [0023] of the Detailed Description section Walker clearly states: “The supplemental protein mixture can include any type and/or amount of protein so long as it can be soluble in the liquid protein mix and includes one or more sulfur containing amino acids. Example of suitable sulfur containing amino acids includes cysteine, methionine, and derivatives of these.” Accordingly, Walker does disclose wherein one sulfur containing amino acid is used without the other as indicated by the term “one”. Additionally, in paragraph [0025] Walker discloses an embodiment that includes at least cysteine. Which reads on cysteine can be present without the addition of methionine. Furthermore, while it is true that table 1 of Walker teaches additional amino acids, it is taught as the amino acid content of collagen (para 37 of walker). Since, instant claims 1 and 16 both include collagen, none of the components of table 1 are excluded from the instant invention.
Applicant traverses the rejection arguing that Hess requires “fatty materials” and teaches away from a composition not including fatty materials (Applicant’s remarks page 10).
Applicant’s argument has been fully considered but not found persuasive. When references are combined in a 103 type rejection, it does not mean that the components of the primary reference need to be combined with all the components of the secondary reference. The claimed combination of references cannot change the principle of operation of the primary reference or render the primary reference inoperable for its intended purpose. See MPEP § 2143.01, subsection VI, not the secondary reference as Applicant has argued.
Applicant traverses the 103 rejection arguing that Clinger alone or combination would not cure the deficiency of the consisting of language as stated above (Applicant’s remarks page 11).
Applicant’s argument has been fully considered, but not found persuasive. For the reasons of record and as explained above including that Walker does not require a second sulfur amino acid, there is no deficiency of “consisting of” that Clinger is required to cure.
For the above reasons and the reasons of record, the obviousness the rejections are maintained.
Non-Statutory 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, 3-6, 8-14, and 16 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/595,874 (reference application) for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1, 3-6, 8-14, and 16 are obviated by claims 1-16 of the reference application as providing for similar components and forms of the formulation.
It would be obvious to one of ordinary skill in the art at the time of instant application to have used the claims of the reference application and achieve the instant invention. The reference application teaches every structural component and concentration limitations of the instant invention. Thus, one would achieve the instant invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s Remarks filed on 11/15/2024 will now be addressed.
Regarding the non-statutory rejection over copending Application No. 17/595,874, Applicant recites “In response, Applicant respectfully submits that terminal disclaimers would be premature at this stage in prosecution because the present claims have not yet been allowed, and thus, the final version of these claims is not yet known. At a time when the claims of the present application are otherwise allowable, Applicant will reconsider any remaining double patenting rejections.”
Applicant’s statement has been fully considered. In the interest of compact prosecution all rejections are made at the earlies possible time in prosecution. Thus, this rejection is maintained at this time.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA R FALKOWITZ whose telephone number is (571)270-3386. The examiner can normally be reached Monday - Friday 9am-5pm.
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/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600