DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 09/16/2025.
Claims 1-6 are pending and subject of this office action
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 112(a)
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 4-6 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. Claim -4 recites “method of treatment”. Nowhere applicant disclosed specific method of treatment using the claimed transdermal delivery composition. Applicants did not disclose what is the “method of treating”? Treating what condition or disorder? No method of treatment using the claimed transdermal composition was disclosed with sufficient specificity.
The expression “method of treating using transdermal delivery of therapeutic agent ….” without partial or complete description of what conditions or disorders are treated, one of ordinary skill in the art that applicants were in possession of the claimed subject matter. The expression does not meet the written description requirement for the claimed expression as one of ordinary skill in the art could not recognize or understand the “method of treating using transdermal delivery of therapeutic agent….” from the mere recitation of the expression. Claims employing limitations at the point of novelty, such as applicants’, neither provide those elements required to practice the inventions, nor “inform the public” during the life of the patent of the limits of the monopoly asserted. The expressions could encompass myriad of compositions and method of their use for treating any disease, disorder, condition, syndrome, etc., systemic and topical, and applicant’s claimed expression represent only an invitation to experiment regarding possible method for treating any possible conditions, diseases, etc. Applicant did not describe any conditions or disordered treated using the claimed composition.
Regarding the requirement for adequate written description, Applicants' attention is directed to MPEP § 2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F. 3d 1559, 1568 (Fed. Cir. 1997), cert denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish list or plan for obtaining the claimed chemical invention." Eli Lilly, 119 F. 3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem Inc. v. Gen-Probe Inc., 296 F. 3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. At 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216,225 (W.D.N.Y. 2003).
To satisfy the written description requirement, the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed.Cir.2008) (quoting In re Alton, 76 F.3d 1168, 1172 (Fed.Cir.1996)). In other words, the applicant must `convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and demonstrate that by disclosure in the specification of the patent.
Written description requirement, serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed. Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed.Cir. 2005). The requirement serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time. (Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed.Cir.2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed.Cir.2002)). A patentee can lawfully claim only what he has invented and described, and if he claims more his patent is void; Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed.Cir.2000). The purpose of the written description requirement is to ensure that the scope of the right to exclude and does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.
Regardless whether a compound or composition is claimed or a method is claimed that entails the use of the compound or composition, the inventor cannot lay claim to that subject matter unless he can provide a description of the claimed subject matter sufficient to distinguish infringing compound/composition from non-infringing compound/composition, or infringing methods from non-infringing methods. Where the specification provides only constructive examples in lieu of working examples, it must still "describe the claimed subject matter in terms that establish that the applicant was in possession of the claimed invention, including all of the elements and limitations." Id. (citing Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed.Cir.1998)).
Federal Circuit decision in Ariad Pharmaceuticals, Inc v. Eli Lilly. 598 F. 3d 1336 - Court of Appeals, Federal Circuit, 2010 – It explains that the written description requirement applies to both original and amended claims. It had further explained that the test for written description is “possession as shown in the disclosure” and embraced past ways for judging the adequacy of the disclosure, including whether the specification discloses a representative number of species, sufficient structure, and/or a sufficient correlation of function to structure.
"Whether the written description requirement is satisfied is a fact-based inquiry that will depend on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed." Carnegie Mellon, 541 F.3d at 1122 (citing Enzo, 323 F.3d at 963). The written description requirement is not satisfied by "[t]he appearance of mere indistinct words in a specification or a claim, even an original claim. . . . A description of what a material does, rather than of what it is, usually does not suffice." Enzo, 323 F.3d at 968 (citing Eli Lilly, 119 F.3d at 1568); see Rochester, 358 F.3d at 926 ("[G]eneralized language may not suffice if it does not convey the detailed identity of an invention.").
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 4-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: “method of treatment”, treatment of what? and step of “applying”, applying where? What the method is used for, and where to apply the treatment?
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Marchant et al. (US 2008/0311358, of record), Changoer et al. (US 2016/0235661, of record), the article by Yeager et al. (“What’s new in photoprotection: A review of new concept and controversies” of record), Bertaina et al. (US 2020/0060959, currently cited on PTO 892), and optionally, further combined with Weller et al. (US 2020/0330543, currently cited on PTO 892).
Applicant Claims
Claim 1 is directed to a composition for transdermal delivery of therapeutic agent, comprising:
an aqueous gel comprising:
a cross-linked sodium hyaluronate polymer aqueous gel therapeutically effective amounts of:
carnosine in a concentration of 0.1%-0.2%;
aloe vera gel;
alpha-tocopherol in an amount 0f 400-500 IU; and
an extract of the Silybum marianum plant;
wherein the cross-linked sodium hyaluronate polymer enhances absorption across cell membranes through endocytosis.
Claim 4 is directed to a method of treatment using transdermal delivery of therapeutic agents, comprising the step of:
applying a cross-linked sodium hyaluronate polymer aqueous gel to a human’s skin from a dispenser, the aqueous gel comprising:
carnosine in a concentration of 0.1-0.2%;
aloe vera gel;
alpha-tocopherol in an amount 0f 400-500 IU; and
an extract of the Silybum marianum plant;
wherein the cross-linked sodium hyaluronate polymer enhances absorption across cell membranes through endocytosis.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Marchant teaches hydrogel composition useful for transdermal delivery of active ingredients in personal care, health care and medicine application. The composition is useful for skin firming, restructuring and as skin antioxidant (abstract; ¶ 0001). Hydrogel is gel that absorb water, i.e. aqueous gel, dispensed from a device (¶¶ 0001, 0005-0006, 0028, 0075, 0125-0126). The composition comprises the following active agents: antiaging agents called Ameliox™ that is a mixture of carnosine, vitamin E and Silybum marianum extract. The composition comprises additional agents including moisturizing skin firming agent including aloe vera in any form; antioxidants including carnosine, α-tocopherol; micro-organism ferment lysate for DNA repair; and product of milk fermentation with Lactobacillus and Lactobacillus extract as collagen synthetic stimulating substance (¶¶ 0138, 0140-0142, 0145, 0156, 0164, 0187-0191, 0196, 0200, 0203, 0207, 0224; claims).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Marchant carnosine, aloe vera extract, vitamin E and Silybum marianum extract, in a composition and method of treating, however, the reference does not teach single embodiment including all the claimed ingredients.
While Marchant teaches aqueous gel, the reference however does not teach crosslinked sodium hyaluronate aqueous gel as claimed by claims 1 and 4.
Marchant does not teach the claimed amount of carnosine of 0.1-0.2%, and amount of alpha tocopherol in the composition as claimed by claims 1 and 4.
Changoer teaches cosmetic and topical formulations for skin firming and soothing and UV ray protection properties (abstract). The topical composition is formulated to be anti-aging cream and nourishing agent (¶¶ 0021, 0033, 0080). The topical composition comprises tocopherol and tocopherol derivatives (vitamin E) as anti-inflammatory, skin conditioning and antioxidant, Silybum marianum fruit extract or silymarin as antioxidant, aloe vera extract as antimicrobial agent, and carnosine as skin conditioning agent. Skin conditioning agents are present in amount between 0.01-30% of the composition (¶¶ 0049-0053, 0058, claims).
Yeager teaches combination of photolyases including and carnosine as antioxidants in topical composition provides the greatest reduction of free radical-induced UV ray damage of dermal proteins when compared by sunscreens using either ingredient alone. Topical antioxidants include tocopherol, aloe vera, and Silybum marianum or Silymarin milk thistle (see the entire document, and in particular the abstract; page 150, right column; Table 4).
Bertaina teaches an aqueous crosslinked hyaluronic acid gel useful in tissue repair reconstruction, and filling wrinkles (abstract; ¶ 0012).
Weller teaches α-tocopherol used as preservative in topical formulation, and has useful antioxidant effect at dose 250-1400 IU (¶ 0107).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide aqueous gel composition for treating skin conditions, skin firming, skin restructuring and providing antioxidant skin effect, wherein the composition comprises carnosine, aloe vera gel, α-tocopherol, and extract of Silybum marianum as taught by Marchant, and surely and confidently use combination of tocopherol, Silybum marianum fruit extract and aloe vera as taught by Changoer, and further combine carnosine taught by Yeager. One would have been motivated to do so because Changoer teaches combination of tocopherol, Silybum marianum fruit extract and aloe vera provides anti-aging, nourishing, cleansing and conditioning skin effect, and Yeager teaches combination of carnosine with antioxidants including tocopherol, aloe vera, and Silybum marianum in topical composition provides the greatest reduction of free radical-induced UV ray damage of dermal proteins when compared by sunscreens using either ingredient alone. One would reasonably expect formulating topical aqueous gel composition comprising carnosine, aloe vera gel, tocopherol and extract of Silybum marianum that successfully treats skin aging, moisturizes, conditions the skin while having great antioxidant effect.
Further one having ordinary skill in the art would have replaced the aqueous gel taught by the combination of Marchant, Changoer, and Yeager with crosslinked aqueous gel of crosslinked hyaluronic acid taught by Bertaina because Bertaina teaches aqueous crosslinked hyaluronic acid gel is useful in tissue repair reconstruction, and filling wrinkles.
Optionally, furthermore, one having ordinary skill in the art would have used α-tocopherol in a dose of 250-1400 IU as taught by Weller because Weller teaches the antioxidant effect of such dose. In any event, one having ordinary skill in the art would have determined the amount desired amount of α-tocopherol IU based on the used formulation and the desired effect.
Regarding the concertation of carnosine as claimed by claims 1 and 4 of 0.1-0.2%, Changoer teaches 0.01-30% that embraces the claimed dose. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5]. Applicants failed to show unexpected results obtained from the claimed concentration. One having ordinary skill in the art would have determined the concentration of carnosine from the concentration taught by the reference based on specific intended use.
Regarding the limitation of applying from dispenser as claimed by claims 4, Marchant teaches a device to deliver the hydrogel.
Regarding the property of crosslinked sodium hyaluronate to enhance absorption across cell membrane through endocytosis as claimed by claims 1 and 4, this is a property of the crosslinked sodium hyaluronate of the prior art that is inseparable from the crosslinked hyaluronate since same compounds cannot have mutually exclusive characteristics.
Regarding silymarin claimed by claims 2 and 5, Marchant, Changoer and Yeager teach silymarin milk.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Marchant, Changoer, Yeager, Bertaina, and optionally Weller and as applied to claims 1-2 and 4-5 above, and further in view of Lundqvist et al. (US 2023/0241134, of record).
Applicant Claims
Claims 3 and 6 recite the composition and method of claims 1 and 4 further comprises Lactobacillus ferment lysate.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Marchant, Changoer, Yeager, Bertaina, and optionally Weller are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Marchant teaches the topical composition comprises micro-organism ferment and lysate as DNA repair agents, and teaches product of milk fermentation with Lactobacillus and Lactobacillus extract as collagen synthetic stimulating substance, the reference however does not explicitly teach Lactobacillus ferment lysate as claimed by claims 3 and 6.
Lundqvist teaches topical cosmetic composition comprising probiotic bacteria that shows improved storage and stability while being beneficial for the user for cosmetic purpose. The composition comprises bacterial lysate and ferment including Lactobacillus to avoid instability of live bacteria (abstract; ¶¶ 0001, 0010, 0057, 0076).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide composition comprising carnosine, aloe vera gel, vitamin E and extract of Silybum marianum that may comprise bacterial lysate and Lactobacillus ferment as taught by the combination of Marchant, Changoer, Yeager, Bertaina and optionally Weller, and include both Lactobacillus ferment and lysate taught by Lundqvist in the topical composition. One would have been motivated to do so because Lundqvist teaches topical cosmetic composition comprising probiotic bacteria, e.g. Lactobacillus ferment and lysate, shows improved storage and stability while being beneficial for the user for cosmetic purpose, unlike instable live bacteria. One would reasonably expect formulating topical composition comprising carnosine, aloe vera gel, vitamin E, extract of Silybum marianum and Lactobacillus ferment and lysate that has beneficial cosmetic effect while being stable at storage.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 09/16/2025 have been fully considered but they are not persuasive.
Rejection under 35 U.S.C. §112(a)
Applicants argue that the specification describes therapeutic conditions to be treated, and refer to many paragraphs in the specification for disclosure of treatment of many conditions.
In response to this argument, and with careful recourse to the specification, applicants disclosed the effect of different agent on some conditions. For example, the effect of vitamin C and niacinamide, that are not claimed on acne; the effect of cannabis that is not claimed on brain related disorder, nausea, neurodegenerative diseases, pain, etc. However, no specific disclosure of the effect of the claimed combination of ingredients on treatment of specific conditions. Applicants disclosure did not satisfy the written description for the claimed method for treating.
Rejection under 35 U.S.C. §112(b)
Applicants argue that the amended claims to recite the ingredients overcome the rejection.
In response to this argument, it is argued that the amendment did not define the claimed method of claims 4-6, and the claims are omitting essential steps of: “method of treatment”, treatment of what? and step of “applying”, applying where? What the method is used for, and where to apply the treatment?
Rejection under 35 U.S.C. §103(a)
Applicants argue that the cited references do not teach the claimed crosslinked sodium hyaluronate (HA) and its functional properties, the concentration of carnosine and the dose of α-tocopherol.
In response to this argument, it is argued that crosslinked HA is taught by the newly cited reference to Bertaina as set forth in this office action. Regarding the functional properties, it is inseparable from the crosslinked HA taught by the cited references and expected from the prior art provided above. The claimed concentration of carnosine od 0.1-2% is suggested by Changoer. Note the claimed amount is 0.1-0.2% and not up to 2%. The claimed amount fall within that taught by Changoer. One having ordinary skill in the art would have determined amount based on the condition to be treated, method and site of application. Regarding the claimed dose of α-tocopherol, it was known before the effective fining date of the present invention to use dose overlapping with the claimed dose as antioxidant to the formulation in vitro.
Applicants argue that there is no reasoned motivation to combine the cited references, and there is lack of the teaching of the HA and its mechanism of action and the claimed amounts.
In response to this argument, it is argued that motivation to combine the references exists, and reasonable expectation to achieve the present invention was provided, even if different from what applicants had done. The amounts were suggested as set forth in this office action. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, motivation to combine the cited references was suggested by the cited references as set forth in this office action. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason.
Applicants argue that the motivation provided by the examiner focused on general antioxidant and anti-aging benefits and not on the specific claimed engineered delivery mechanism of the claimed crosslinked HA. Combination of the references would not provide the claimed technology.
In response to this argument, it is argued that the currently standing rejection teach all the ingredients of the claimed composition and steps of the claimed method of using the composition. In determining obviousness, neither the particular motivation to make the claimed invention nor the problem the inventor is solving controls. The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts. See 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a). Factors other than the disclosures of the cited prior art may provide a basis for concluding that it would have been obvious to one of ordinary skill in the art to bridge the gap. See MPEP 2141, section III.
The discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness.
The obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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