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 .
Status of the Application
Claims 24-36, 38, 39, 41-45 are pending and under current examination.
Amendment necessitated new claim rejection set forth below.
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 25, 27, 29, 31 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 25, 26, 29, 31 are indefinite because:
claim 25 recites “molecular weight ----30 to about 60kDa, optionally about 35 to about 60kDa, optionally---45 to about 55kDa”, which reflects use of broad and narrow limitation of molecular weight within the same claim. Thus, making scope of claim unclear. For compact prosecution, molecular weight in the claim has been interpreted as about 30 to about 60kDa.
Claims 27, 28, 29, 31, 32, 35 recites “is selected from---”. This is because the claim is an open ended improper Markush format. To overcome this rejection applicant is suggested to amend the claim, such as “is selected from a group consisting of”. Please see MPEP 2173.05(h)
Appropriate correction required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 44-45 are rejected under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 44-45 are in an improper dependent form because:
According to claim 31, the composition may comprise histidine. Claims 44-45 dependent on claim 31 recites “thiourea derivative of histidine”, which makes claim improper and broader than claim 31. This is because, histidine is well-defined amino acid and does not include derivatives that are different from structure of histidine.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 24-30, 35, 36, 38, 39 and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Somerville (US 8980228 B2) and Johncock (US 20220071872 A1) in combination.
Determining the scope and contents of the prior art
Somerville disclose a skin care composition comprising HA or its sodium salt sodium hyaluronate of molecular weight of about 50kDa in an amount of 0.5%, 1%, 3%, or 5% by weight based on total weight of the composition, vitamin C or derivatives thereof including ascorbyl palmitate, ascorbyl glucoside etc. in an amount of 0.005-5% by weight based on total weight of the composition with example of 0.1% by weight
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, niacin (vitamin B) and other vitamins (reads on HA, sodium salt of HA, molecular weight of HA, amount of HA, ascorbic acid, ascorbyl glucoside of the instant claims 24-29, 35-41) (entire patent, especially abstract, col 2, 4-8, Table 1 and Table 3 and claims).
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Ascertaining the differences between the prior art and the claims at issue
Somerville teaches a skin care composition having HA, sodium salt of HA, molecular weight of HA, amount of HA, ascorbic acid, ascorbyl glucoside of the instant claims. The cited prior art further teaches composition with vitamin B3, such as niacin and amount of hydrophilic vitamin in the composition as 0.005-5% (overlaps with range of the instant claims), but fails to teach vitamin B3 as niacinamide; example of a composition with hydrophilic vitamin within range of the instant claims; and carnosine in the composition.
Resolving the level of ordinary skill in the pertinent art
With regards to the difference of niacinamide in the composition-The cited prior art teaches composition with vitamin B3 with example of niacin. Thus, with the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with reasonable expectation of success that vitamin B3 niacin may be substituted with another vitamin B3 niacinamide in the composition.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
With regards to the difference of amount of hydrophilic vitamin in the composition as 1-25% by weight based on total weight of the composition- The cited prior art teaches amount of hydrophilic vitamin in the composition as 0.005-5% by weight based on total weight of the composition (overlaps with range of the instant claims). Thus, with the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with reasonable expectation of success that the composition may have hydrophilic vitamin in an amount of as 1-5% by weight based on total weight of the composition as taught by the cited prior art.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
With regards to carnosine in the composition, Somerville is silent about it. This deficiency is cured by Johncock.
In the same field of endeavor of skin care composition, Johncock teaches skin care composition comprising hyaluronic acid or salt thereof, vitamin C (with examples of ascorbyl palmitate, ascorbyl acetate etc.,), or B or combination thereof, carnosine (entire article, especially paragraphs 0191, 0199, 0286, 0301, 0304).
Thus, based on the combination of the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that the skin care composition may comprise carnosine.
Further, case law has established that “It is obvious to combine two compositions taught by the prior art to be useful for the same purpose to form a third composition that is to be used for the very same purpose.” In re Kerkehoven, 626 F.2d 846, 205 U.S.P.Q. 1069 (CCPA 1980). Thus, the combination reads on the instant claims.
With regard to limitations of the claims 38 and 39 “amount of the HA---effective to increase---permeation of the hydrophilic vitamins in the skin”- Since the cited prior art teaches same composition with same ingredients including hydrophilic vitamins and in same amounts as in the instant claims, the composition, the hydrophilic vitamins and their amounts of the cited prior art are also expected to be capable of same “amount of the HA---effective to increase---permeation of the hydrophilic vitamins in the skin”.
Based on the above established facts, it appears that the teachings of above cited prior art read applicants’ composition.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have combined the elements as claimed with no change in their respective functions, and would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Somerville teaches a skin care composition having HA, sodium salt of HA, molecular weight of HA, amount of HA, ascorbic acid, ascorbyl glucoside of the instant claims. Johncock teaches skin care composition comprising hyaluronic acid or salt thereof, vitamin C (with examples of ascorbyl palmitate, ascorbyl acetate etc.,), or B or combination thereof, carnosine
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that carnosine may be present in the composition and can be made by teachings of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed composition with a reasonable expectation of success.
Claims 24-36, 38, 39, 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Somerville (US 8980228 B2), Nabi (US20190008739 A1), and Johncock (US 20220071872 A1) in combination.
Determining the scope and contents of the prior art
Somerville disclose a skin care composition comprising HA or its sodium salt sodium hyaluronate of molecular weight of about 50kDa in an amount of 0.5%, 1%, 3%, or 5% by weight based on total weight of the composition, vitamin C or derivatives thereof including ascorbyl palmitate, ascorbyl glucoside etc. in an amount of 0.005-5% by weight based on total weight of the composition with example of 0.1% by weight
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, niacin (vitamin B) and other vitamins (reads on HA, sodium salt of HA, molecular weight of HA, amount of HA, ascorbic acid, ascorbyl glucoside of the instant claims 24-29, 35-41) (entire patent, especially abstract, col 2, 4-8, Table 1 and Table 3 and claims).
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Ascertaining the differences between the prior art and the claims at issue
Somerville teaches a skin care composition having HA, sodium salt of HA, molecular weight of HA, amount of HA, ascorbic acid, ascorbyl glucoside of the instant claims. The cited prior art further teaches composition with vitamin B3, such as niacin and amount of hydrophilic vitamin in the composition as 0.005-5% (overlaps with range of the instant claims), but fails to teach vitamin B3 as niacinamide; example of a composition with hydrophilic vitamin within range of the instant claims; composition with amino acids taurine, arginine and glycine in weight ratio range from about 85:45:1 to about 45:24:1 or with carnosine.
Resolving the level of ordinary skill in the pertinent art
With regards to the difference of niacinamide in the composition-The cited prior art teaches composition with vitamin B3 with example of niacin. Thus, with the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with reasonable expectation of success that vitamin B3 niacin may be substituted with another vitamin B3 niacinamide in the composition.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
With regards to the difference of amount of hydrophilic vitamin in the composition as 1-25% by weight based on total weight of the composition- The cited prior art teaches amount of hydrophilic vitamin in the composition as 0.005-5% by weight based on total weight of the composition (overlaps with range of the instant claims). Thus, with the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with reasonable expectation of success that the composition may have hydrophilic vitamin in an amount of as 1-5% by weight based on total weight of the composition as taught by the cited prior art.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
With regards to the difference of composition with amino acids taurine, arginine and glycine in weight ratio range from about 85:45:1 to about 45:24:1-This deficiency is cured by Nabi.
In the same field of endeavor, Nabi teaches a skin care composition comprising HA, vitamins, such as vitamin B3 and amino acid combination of taurine, arginine and glycine in weight ratio range such as (64-69):(30-35):1, 65:34:1, 69:30:1 (all are within range of from about 85:45:1 to about 45:24:1 of the instant claims) (entire application, especially abstract, paragraphs 0004-0057 and claims). The cited prior art further teaches that combination of taurine, arginine and glycine reduces skin irritation, inflammation and improves barrier repair of the skin (entire application, especially abstract, paragraphs 0004-0057 and claims). Thus, based on the guidance provided by Somerville and Nabi, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that the skin care composition having HA and hydrophilic vitamin may have combination of taurine, arginine and glycine in weight ratio as disclosed by Nabi. Further, a person of ordinary skill in the art would have been motivated to combine teachings of Somerville with Nabi to form an improved composition that reduces skin irritation, inflammation and improves barrier repair of the skin.
Additionally, it is obvious to combine two compositions taught by the prior art to be useful for the same purpose to form a third composition that is to be used for the very same purpose. In re Kerkehoven, 626 F.2d 846, 205 U.S.P.Q. 1069 (CCPA 1980).
With regards to carnosine in the composition, Somerville is silent about it. This deficiency is cured by Johncock.
In the same field of endeavor of skin care composition, Johncock teaches skin care composition comprising hyaluronic acid or salt thereof, vitamin C (with examples of ascorbyl palmitate, ascorbyl acetate etc.,), or B or combination thereof, carnosine (entire article, especially paragraphs 0191, 0199, 0286, 0301, 0304).
Thus, based on the combination of the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that the skin care composition may comprise carnosine.
Further, case law has established that “It is obvious to combine two compositions taught by the prior art to be useful for the same purpose to form a third composition that is to be used for the very same purpose.” In re Kerkehoven, 626 F.2d 846, 205 U.S.P.Q. 1069 (CCPA 1980). Thus, the combination reads on the instant claims.
With regard to limitations of the claims 38 and 39 “amount of the HA---effective to increase---permeation of the hydrophilic vitamins in the skin”- Since the cited prior art teaches same composition with same ingredients including hydrophilic vitamins and in same amounts as in the instant claims, the composition, the hydrophilic vitamins and their amounts of the cited prior art are also expected to be capable of same “amount of the HA---effective to increase---permeation of the hydrophilic vitamins in the skin”.
Based on the above established facts, it appears that the teachings of above cited prior art read applicants’ composition.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have combined the elements as claimed with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Somerville teaches a skin care composition having HA, sodium salt of HA, molecular weight of HA, amount of HA, ascorbic acid, ascorbyl glucoside of the instant claims. Nabi teaches a skin care composition comprising HA, vitamins, such as vitamin B3 and amino acid combination of taurine, arginine and glycine in weight ratio range such as (64-69):(30-35):1, 65:34:1, 69:30:1. Johncock teaches skin care composition comprising hyaluronic acid or salt thereof, vitamin C (with examples of ascorbyl palmitate, ascorbyl acetate etc.,), or B or combination thereof, carnosine
So, the combination reads the instant claims.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that the skin care composition with HA and hydrophilic vitamin may be combined with amino acids taurine, arginine and glycine and carnosine and can be made by teachings of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed composition with a reasonable expectation of success.
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 24-36, 38, 39, 41-45 in the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11938212 B2, since the claims, if allowed, would improperly extend the “right to exclude" already granted in the patent.
Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of instant application and 1-10 of U.S. Patent No. 11938212 B2 are drawn to a composition comprising HA, hydrophilic vitamin and amino acids taurine, arginine and glycine with a difference of scope.
The difference of scope, however, does not constitute a patentable distinction, because the claims in the present invention simply fall within the scope of claims 1-10 of U.S. Patent No. 11938212 B2. For the foregoing reasons, the instantly claimed composition is made obvious.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See also MPEP § 804.
Claims 24-36, 38, 39, 41-45 in the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over the claims 49, 53, 54, 56, 59-61, 64-71, 75 and 76 of co-pending US application 18194527. Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of instant application and co-pending application are drawn to a composition comprising HA, hydrophilic vitamin and amino acids taurine, arginine and glycine with a difference of scope.
The difference of scope, however, does not constitute a patentable distinction, because the claims in the present invention simply fall within the scope of co-pending application. For the foregoing reasons, the instantly claimed composition is made obvious.
This is provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Response to Arguments
Applicant’s remarks and amendment, filed on 06/09/2026, have been fully considered but not found persuasive.
Applicant argued over rejection under 112b:
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This is not found persuasive and the instant claims stand rejected under 112b. This is because claim 25 is in fact ambiguous and unclear with respect to metes and bounds of the claim. The “outer boundary” provides a broader range and subranges introduces narrower ranges.
Rest of applicant’s argument is moot in view of new rejection as set forth above.
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.
Conclusion
No Claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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