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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/HU2020/000026 filed 09/15/2020, which claims the benefit of the priority of Hungary Patent Application No. P1900257 filed 07/18/2019 and P2000094 filed 03/12/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 3, 5, and 24-28 are pending. Claims 3, 5, 25-28 are amended. Claims 1-2, 4, 6-23, 29-43 are canceled. Claims 3, 5, and 24-28 are being examined on the merits in this office action.
Claim Objections - Withdrawn
The objection of claim 5, and 25 is withdrawn in view of the claim amendments.
The rejection of claims 5, and 27 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the claim amendments.
Claim Objections - Modified
Claim 26 remains objected to because of the following informalities:
Claim 26 recites “appr.”. The claim should be amended to recite “approximately”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 - Modified
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 25-26 remain 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.
Regarding claim 25, the claim contain a parenthesis in claim 25, line 7. It is unclear whether the limitations in the parenthesis are a required part of the claimed invention.
Regarding claim 26, the claim contain a parenthesis in claim 25, line 3-5. It is unclear whether the limitations in the parenthesis are a required part of the claimed invention.
Claim Rejections - 35 USC § 112 - New
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.
Claim 3, 5, and 24-28 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. This is a NEW MATTER rejection.
The response filed 01/28/2026 has introduced NEW MATTER into the claims. The newly added/amended Claim(s) 3, 27 recites “intravesical residence” and “mucosal compatibility”. The response did not specifically and adequately point out where support for newly added/amended Claim(s) 3 and 27 could be found in the originally filed disclosure.
Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”).
The amended claims now recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in newly amended claim, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. “Intravesical residence” and “mucosal compatibility” is not found at all in the disclosure. Applicant is required to provide sufficient written support for the limitations recited in the present claims in the specification, or claims as-filed, or remove these limitations from the claims in response to this Office Action.
Claim Rejections - 35 USC § 103 - Maintained
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 3 and 5 remain rejected under 35 U.S.C. 103 as being unpatentable over Parsons (US20050234013A1 – hereinafter “Parsons”) in view of Hahn (US6083933A – hereinafter “Hahn”).
Parsons teaches a formulation that comprises heparinoid, a local anesthetic, and a buffering compound (claim 1, 7; [0009]), wherein the heparinoid comprises at least one of a heparin, a pentosan polysulfate sodium, a heparan sulfate, a heparin sodium, a hyaluronic acid, and a chondroitin sulfate (claim 7, [0010]). Parsons further teaches that the buffering compound comprises at least one of sodium bicarbonate (claim 13) which reads on alkaline basic. Parsons teaches that the composition further comprises an osmolar component such as sodium chloride (claims 3-4; [0108-0110]), which reads on alkaline salt and that the NaCl is in water [0080]. Parsons further teaches that the composition comprises water [0034, 0080, 0096, 0113]. Parsons teaches that salts of the compounds may be prepared [0094]. Parsons teaches the composition for treating interstitial cystitis (claim 41). Parsons teaches 500 units of heparin to about a maximum of 100,000 units of heparin [0099], 10 mg to about 600 mg of heparin sodium [0104]. Parsons teaches that the composition is for repairing a mucin layer of bladder tissue thereby inhibiting Interstitial cystitis, the mucus layer containing GAGs [0133, 0178]. Parsons teaches that the composition is compatible with the salinity found in most mammalian cells and in human blood, that therapeutic composition may also contain an osmolar component that provides an isotonic or nearly isotonic solution compatible with human cells and blood [0080-0081, 0108, 0114]. Parsons teaches that the composition is for intravesical administration [0013, 0023, 0025, 0051].
Examiner notes that Parsons teaches all the components of the instant composition but does not necessarily teach that the chondroitin sulfate is an alkaline salt of chondroitin sulfate.
Hahn teaches a composition for treating Interstitial Cystitis comprising Na Chondroitin Sulfate, Sodium Chloride, and sterile water (Col. 6, line 35-45). Hahn teaches that other agents that can be included are glycosaminoglycans (GAGs) such as the various forms of hyaluronic acid, other forms of chondroitin sulfate and other forms of heparin (Col. 5, line 40-45). Hahn teaches that the composition is adapted for delivery by instillation to alleviate at least one of the symptoms that elicited in a cystitis patient (col. 1, line 61-67). Hahn teaches that the pH is adjusted to 7.2 by sodium hydroxide (Col. 6, line 56-57) which is the alkaline basic.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Parsons and use Na Chondroitin Sulfate of Hahn since Hahn teaches that compositions comprising Na Chondroitin Sulfate was used for treatment of cystitis. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using an alkaline salt of chondroitin sulfate in the composition since Hahn teaches the composition is adapted for delivery by instillation to alleviate at least one of the symptoms that elicited in a cystitis patient (col. 1, line 61-67).
Regarding claim 5, Parsons teaches that the composition was used to treat a disorder of the lower urinary tract, and in particular, reducing the symptoms (including treatment) of interstitial cystitis (Abstract; claims 20, 41). Parsons teaches that the composition is for repairing a mucin layer of bladder tissue thereby inhibiting Interstitial cystitis, the mucus layer containing GAGs [0133, 0178].
Claims 24-28 remain rejected under 35 U.S.C. 103 as being unpatentable over Parsons (US20050234013A1 – hereinafter “Parsons”) in view of Hahn (US6083933A – hereinafter “Hahn”) as applied to claim 3 above, and further in view of Formulary (North Yorkshire and Yolk Formulary, published 04/07/2004) and Meier et al. (EP3400950A1 – hereinafter “Meier”).
The teaching of the EP3400950A1 publication are based on the English language translation of the EP3400950A1 publication obtained by Espacenet and the citations are based on the English language translation.
The teachings of Parsons and Hahn are disclosed above and incorporated herein by reference.
Parsons does not teach that the hyaluronic acid is sodium hyaluronate as recited in claim 24.
Formulary teaches a composition for treatment of bladder disorders, wherein the composition is iALuril and the composition comprises Sodium hyaluronate 1.6% w/v (800mg in 50mL), Sodium chondroitin sulphate 2% w/v (1g in 50mL), and Calcium chloride 0.87% (440mg in 50mL) (Page 1).
Meier teaches a composition comprising chondroitin sulfate salt (chondroitin sulfate sodium) and component in the form of sodium hyaluronate and water [0222]. Meier teaches that the composition comprises sodium chloride [0226], sodium hydroxide [0221], and that the composition has an osmolality of 150 mosmoles/kg to 600 mosmoles/kg, in particular in the range from 200 mosmoles/kg to 550 mosmoles/kg, preferably in the range from 250 mosmoles/kg to 500 mosmoles/kg, preferably in the range from 275 mosmoles/kg to 450 mosmoles/kg, particularly preferably in the range from 300 mosmoles/kg to 400 mosmoles/kg [0133, 0227]. Meier teaches that the composition comprises alkaline earth metal constituents in particular calcium salt concentration or magnesium salt concentration, of at most 1 mg/ml, in particular at most 0.5 mg/ml, preferably at most 0.1 mg/ml, preferably at most 0.05 mg/ml, particularly preferably at most 0.01 mg/ml [0149-0151] and that the composition has a pH of 6.6 to 7.7 [0199-0200]. Meier teaches that the composition comprises 16 ± 1.6 mg/ml hyaluronic acid and/or a physiologically acceptable hyaluronic acid salt (hyaluronate), 20±2 mg/ml chondroitin sulfate [0058] and sodium chloride at a concentration of 8mg/ml [0123]. Meier teaches that the composition comprising the components has improved stability, in particular storage stability, with simultaneously high efficacy or efficacy and very good compatibility [0059].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Parsons and use Na hyaluronate of Formulary and Meier which has been used to treat bladder disorders. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using Na hyaluronate in the composition since Formulary teaches the composition comprising Na hyaluronate and for the treating of the instant condition and Meier teaches that the composition comprising Na hyaluronate and chondroitin sulfate had high efficacy or efficacy and very good compatibility [0059].
Regarding claim 24, Parsons teaches a formulation that comprises heparinoid, a local anesthetic, and a buffering compound (claim 1, 7; [0009]), wherein the heparinoid comprises at least one of a heparin, a pentosan polysulfate sodium, a heparan sulfate, a heparin sodium, a hyaluronic acid, and a chondroitin sulfate (claim 7, [0010]). Parsons further teaches that the buffering compound comprises at least one of sodium bicarbonate (claim 13) which reads on alkaline basic. Parsons teaches that the composition further comprises an osmolar component such as sodium chloride (claims 3-4; [0108-0110]), which reads on alkaline salt. Parsons further teaches that the composition comprises water [0034, 0080, 0096, 0113]. Parsons teaches that salts of the compounds may be prepared [0094]. Parsons teaches the composition for treating interstitial cystitis (claim 41). Parson does not explicitly teach that the hyaluronic acid is Na hyaluronate. However, compositions for use in treating the instant condition are known to have Na-hyaluronate as taught by Formulary. Formulary teaches a composition for treatment of bladder disorders, wherein the composition is iALuril and the composition comprises Sodium hyaluronate 1.6% w/v (800mg in 50mL), Sodium chondroitin sulphate 2% w/v (1g in 50mL), and Calcium chloride 0.87% (440mg in 50mL) (Page 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Parsons and use Na hyaluronate of Formulary which has been used to treat bladder disorders. The disclosures render obvious claim 24.
Regarding claims 25-26, Formulary teaches a composition for treatment of bladder disorders, wherein the composition is iALuril and the composition comprises Sodium hyaluronate 1.6% w/v (800mg in 50mL), Sodium chondroitin sulphate 2% w/v (1g in 50mL), and Calcium chloride 0.87% (440mg in 50mL) (Page 1). Further, Parsons teaches that the composition is an aqueous solution [0034], and teaches 500 units of heparin to about a maximum of 100,000 units of heparin [0099], 10 mg to about 600 mg of heparin sodium [0104] and sodium bicarbonate is in a quantity of about 3 ml of 8.4% sodium bicarbonate (w/v) (claim 15). Meier teaches that the composition comprises alkaline earth metal constituents in particular calcium salt concentration or magnesium salt concentration, of at most 1 mg/ml, in particular at most 0.5 mg/ml, preferably at most 0.1 mg/ml, preferably at most 0.05 mg/ml, particularly preferably at most 0.01 mg/ml [0149-0151] and that the composition has a pH of 6.6 to 7.7 [0199-0200]. Meier teaches that the composition comprises 16 ± 1.6 mg/ml hyaluronic acid and/or a physiologically acceptable hyaluronic acid salt (hyaluronate), 20±2 mg/ml chondroitin sulfate [0058] and sodium chloride at a concentration of 8mg/ml [0123]. Examiner notes that the cited reference teach all the components of the instant composition. In addition, the concentration of the active agent is a result effective variable and the determination of the optimum or workable ranges of said variable may be characterized by routine experimentation (See MPEP 2144 II). It would be obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to combine the teachings of the cited reference and optimize the concentrations of the components to arrive at the concentrations of the instant claims 25-26.
Regarding claims 27-28, Meier teaches that the composition has an osmolality of 150 mosmoles/kg to 600 mosmoles/kg, in particular in the range from 200 mosmoles/kg to 550 mosmoles/kg, preferably in the range from 250 mosmoles/kg to 500 mosmoles/kg, preferably in the range from 275 mosmoles/kg to 450 mosmoles/kg, particularly preferably in the range from 300 mosmoles/kg to 400 mosmoles/kg [0133, 0227]. Meier teaches that the composition has a pH of 6.6 to 7.7 [0199-0200]. It would have been obvious to modify the composition to arrive to the instant concentrations. Further, Parsons teaches that the composition is compatible with the salinity found in most mammalian cells and in human blood, that therapeutic composition may also contain an osmolar component that provides an isotonic or nearly isotonic solution compatible with human cells and blood [0080-0081, 0108, 0114].
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that the scope of the pending claims discloses a defined osmolarity range, a defined pH window, defined specific ratios, specific calcium + sodium ionic system, and stability + mucosal compatibility, that the pending claims define a physicochemically engineered intravesical system in which GAG salts, heparin, ionic species (Na+, Ca2+) and buffering components are selected and proportioned to achieve physiologic osmolarity (280-310 mOsm/l) and urothelial-compatible pH (6.3-8.3), while simultaneously enabling GAG layer replenishment and mucosal compatibility (Page 2 of Arguments).
Applicant argues that the cited art discusses ingredients, not a controlled intravesical physicochemical environment and that the cited art does not teach or suggest a balanced intravesical GAG system designed around urothelial tolerability constraints. Applicant argues that Parsons does not teach GAG-layer restoration, and does not teach sodium hyaluronate and sodium chondroitin sulfate in the claimed system. Parsons also does not address physiologic osmolarity control, does not describe Ca2+ ionic participation, and does not define pH/osmolarity as design constraints. Applicant argues that Hahn teaches a different therapeutic principle, specifically the use of sodium chondroitin sulfate as a GAG supplement. As such, Hahn does not integrate anesthetic or multi-component ionic balancing, does not address intravesical physicochemical optimization, and does not disclose the claimed osmolarity or pH framework. Rather, Hahn represents single-agent GAG therapy, not a buffered multi-component intravesical environment. Thus, Hahn operates on a different therapeutic principle (Page 2-3 of Arguments).
Applicant argues that that there is no motivation to combine because Parsons focuses on anesthetic-based symptom control, while Hahn focuses on GAG supplementation alone, and combining these two different systems introduces ionic interaction changes, osmotic effects, pH sensitivity and stability issues that Parsons does not contemplate and that Parsons' formulation is not designed for GAG-layer structural restoration, ionic-controlled mucosal interface and/or stability of a multi-GAG environment, and the proposed combination with Hahn would fundamentally alter Parsons' purpose and operation. Applicant further argues hindsight reasoning (Page 2-3 of Arguments).
Applicant argues that the Meier does not address GAG/heparin intravesical compatibility and does not teach balancing Na+/Caz+ in a bladder mucosal context. Moreover, the cited art does not recognize osmolarity and pH as functional safety parameters for GAG-containing intravesical systems (Page 3-5 of Arguments).
Applicant argues that the claimed ranges recite a controlled intravesical physicochemical system engineered for mucosal compatibility and GAG-layer restoration, and that the claims reflect physiological urothelial compatibility constraints, not arbitrary formulation choices. The cited art, either alone or in combination, fails to teach or suggest this system (Page 4-5 of Arguments).
Examiner’s response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that Parsons teaches all the components of the claimed invention. Specifically, Parsons teaches an aqueous composition comprising a buffering compound (claim 1, 7; [0009]), heparinoid comprises at least one of a heparin, a pentosan polysulfate sodium, a heparan sulfate, a heparin sodium, a hyaluronic acid, and a chondroitin sulfate (claim 7, [0010]). Parsons further teaches that the buffering compound comprises at least one of sodium bicarbonate (claim 13) which reads on alkaline basic. Parsons teaches that the composition further comprises an osmolar component such as sodium chloride (claims 3-4; [0108-0110]), which reads on alkaline salt and that the NaCl is in water [0080]. Examiner used the Hahn references to teach the specific alkaline salt of chondroitin sulfate, i.e. Na chondroitin sulfate. Examiner notes that Hahn teaches a composition for treating Interstitial Cystitis comprising Na Chondroitin Sulfate, Sodium Chloride, and sterile water (Col. 6, line 35-45). Hahn teaches that other agents that can be included are glycosaminoglycans (GAGs) such as the various forms of hyaluronic acid, other forms of chondroitin sulfate and other forms of heparin (Col. 5, line 40-45). Hahn teaches that the composition is adapted for delivery by instillation to alleviate at least one of the symptoms that elicited in a cystitis patient (col. 1, line 61-67). Hahn teaches that the pH is adjusted to 7.2 by sodium hydroxide (Col. 6, line 56-57) which is the alkaline basic.
Examiner notes that similarly, Hahn teaches all the components of the claimed composition. Applicant assertion that the two references cannot be combined is unpersuasive. The references teach all components in a composition and teaches the composition to treat the instant condition i.e. bladder pain syndrome or interstitial cystitis. Thus, Applicant assertion that Hahn teaches a different therapeutic principle, specifically the use of sodium chondroitin sulfate as a GAG supplement, is unpersuasive. Bothe references teach the instant composition and teach methods of using the composition to treat the instant condition interstitial cystitis. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, 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, both references teach the instant components in a composition to treat the instant condition i.e. bladder pain syndrome or interstitial cystitis. One of ordinary skill in the art would be highly motivated look in to the teachings of Hahn to specifically use the Na Chondroitin Sulfate as the alkaline salt of chondroitin sulfate.
Regarding Applicants argument that the cited references do not disclose the claimed osmolarity or pH framework, Examiner is not convinced. Examiner notes that Hahn teaches that the pH is adjusted to 7.2 by sodium hydroxide (Col. 6, line 56-57). Examiner notes that the pH of Hahn falls within the cited pH. Further, the composition of the cited references comprises the NaCl, which is known to contribute to the osmolarity of the composition. Examiner notes that the cited references teach all the components of the instant composition and combine in the instant way. Thus the composition of the cited references would necessarily comprise the instant osmolarity and pH. This argument is unpersuasive. Applicant argument the pending claims define a physicochemically engineered intravesical system in which GAG salts, heparin, ionic species (Na+, Ca2+) and buffering components are selected and proportioned to achieve physiologic osmolarity (280-310 mOsm/l) and urothelial-compatible pH (6.3-8.3), while simultaneously enabling GAG layer replenishment and mucosal compatibility, is unpersuasive. Examiner notes that the cited references teach the instant composition, thus such compositions to treat the instant conditions are known in the art. Further, Formulary teaches the concentrations of the instant components in a composition to treat the instant condition. So, the concentrations are known in the art. The specific osmolality is also known in the art as taught by Meier. Thus, Applicant assertion that none of the references teaches the ionic species and components in the recited proportions is unpersuasive. Further, Examiner notes that Parsons teaches that the composition is for repairing a mucin layer of bladder tissue thereby inhibiting Interstitial cystitis, the mucus layer containing GAGs [0133, 0178]. Parsons teaches that the composition is compatible with the salinity found in most mammalian cells and in human blood, that therapeutic composition may also contain an osmolar component that provides an isotonic or nearly isotonic solution compatible with human cells and blood [0080-0081, 0108, 0114].
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, a composition that comprises the instant components is known in the art and known to treat the instant conditions. Examiner maintains that the obviousness rejection is not based upon improper hindsight reasoning.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner notes that the obviousness rejection based on the combined teachings of Parsons and Hahn, and Parson, Hahn, Meier and Formulary. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Examiner maintains that when the teachings of the cited references are combined, the instant invention is obvious. The arguments are unpersuasive and the rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/ Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654