DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 7, 2026 has been entered.
Claims 16, 21-22 and 31-63 have been canceled, Claim 64 has been added. Claims 1-15, 17-20, 23-30, and 64 are pending, Claims 10, 12-14, 17-19, 23-30, and 64 have been withdrawn (newly added claim 64 is directed to a treating method using a different composition and injection technique, therefore, claim 64 is withdrawn), and Claims 1-9, 11, 15, and 20 have been considered on the merits, insofar as they read on the elected species of a collagenase composition having characteristics including a potency of about 5,000 to about 25,000 ABC units/mg and less than or equal to 1% by area of an impurity selected from the group consisting of clostripain, gelatinase, and leupeptin (Species 1), the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) (Species 2), at least 50% of the patients show improvement in severity at Day 22, 43, or 71 from baseline of at least 1 level of severity in the CR-PCSS as assessed live by the clinician of the buttocks (Species 3), and a dose of about 1 mg to 20 mg (Species 4). All arguments have been fully considered.
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.
Claims 1-4, 6, 8-9, 11, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hart (US 2014/0335072 A1; 11/13/2014.) in view of Sabatino et al (US 7,811,560 B2; 10/12/2010. Cited on IDS), Endo (Endo. 2016;1-7.), Sivagnanam (Journal of Pharmacology and Pharmacotherapeutics. 2010;1(1):4-8.), and FDA (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf. 2017;1-8.).
The instant claims recite a method of treating cellulite in the buttock of a human patient or a population of patients, the method comprising: a. providing a collagenase composition having a potency of about 5,000 to about 25,000 ABC units/mg and less than or equal to 1% by area of an impurity selected from the group consisting of clostripain, gelatinase, and leupeptin; and b. injecting with a needle aliquots of a therapeutically effective amount of the collagenase composition into a skin surface of the buttock of the patient or the population of patients, wherein the aliquots are injected at a depth of 1/8 inch to 2 inches and at an angle of about 45º from one another without fully removing the needle from the skin surface, and wherein the treating results in an at least 2 level reduction on a Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at 71 days following the injecting.
Hart teaches a method for treating or reducing edematous fibrosclerotic panniculopathy (EFP), more commonly referred to as cellulite, in a human patient (para 0045) comprising administering to said patient one or a plurality of subdermal injections of collagenase to an area affected by EFP (para 0002, 0004, 0006), the dose of collagenase administered depends on the size of the treatment area, and is thus between about 5 to about 5000 ABC units (a therapeutically effective amount) (para 0005), wherein the area affected by EFP is typically an area of the skin on the buttocks characterized by one or more dimples (para 0020), the collagenase is purified from Clostridium histolyticum, the collagenase comprises collagenase I (AUX-I) and collagenase II (AUX-II) (as described in U.S. Pat. No. 7,811,560 by Sabatino) (para 0024), and the small or trace amount of impurity is less than about 1% by area (para 0028).
Hart teaches the contents of U.S. Pat. No. 7,811,560 by Sabatino are expressly incorporated herein by reference herein (para 0024). Sabatino teaches a drug product comprising a combination of collagenase I and collagenase II from Clostridium histolyticum (Abstract), wherein the collagenase composition has less than or equal to 1% by area of an impurity selected from the group consisting of clostripain, gelatinase and leupeptin (col.18 line 44-48, Table A). The collagenase composition comprises AUX-I and AUX-II, wherein kinetic parameters are measured using SRC assay (AUX-I) and GPA assay (AUX-II) (Table A). Most preferably, 1.0 mg of collagenase is used (col.24 line 9). In addition, Hart teaches the method wherein the collagenase is XIAFLEX®, or CCH (para 0024, Table 3), and the instant specification discloses that the claimed collagenase is CCH under the trademark XIAFLEX® (para 00065). Since the collagenase of Hart is the same as the claimed collagenase, the collagenase of Hart would possess the claimed characteristics in claims 1 and 15. Furthermore, Endo teaches women with moderate or severe cellulite are treated with a plurality of CCH injections having a therapeutically effective amount on buttocks for up to three treatment sessions (p.1 para 3), primary endpoint is the proportion of composite responders at Day 71 defined as subjects with a 2-point improvement in severity from baseline in the clinician-reported (CR) PCSS and a 2-point improvement in the patient-reported (PR) PCSS, and additional endpoints include a composite of 1-point responders, the percentage of responders with 1-point and 2-point improvements on the CR-PCSS and PR-PCSS (p.1 last para, p.2 first para). Subjects receiving CCH demonstrated a highly statistically significant improvement in the primary endpoint of composite investigators’ and patients’ assessments of the appearance of cellulite, as measured by a two-point improvement in both the CR-PCSS and PR-PCSS, and subjects receiving CCH demonstrated a highly statistically significant improvement in the composite investigators’ and patients’ assessments of the appearance of cellulite, as measured by a one-point improvement in both the CR-PCSS and PR-PCSS (p.2 para 3).
Hart teaches injections are administered using a ¼ inch needle, and a dose of collagenase is injected perpendicular to the patient’s skin to a depth of ¼ inch (para 0059). Hart does not teach said collagenase is administered by a clinician who does rely on a spacer, ruler, paper, or other device for the injecting. The plurality of injections includes at least one injection administered to the center of one dimple, and the sites of injection can be about 1 to about 4 cm from one another, which overlaps with the claimed space between injections (para 0022). If the area affected by EFP includes one dimple, the geometric area of the target area can be about 1 cm2 to about 5 cm2, the area can be roughly rectangular in shape and have a length of about 1 to about 15 cm, and the sites for injection of collagenase can be numbered and spaced within the area affected by EFP such as to allow for even distribution and efficacy of the injected collagenase (para 0021). It is noted that limitations of “wherein the treating results in … following the injecting” in claim 1, “wherein the method improves the appearance of dimples” in claims 2-3, and “the method results in an outcome …” in claim 11 do not recite any additional active method steps, but simply state a characterization or conclusion of the results of process step positively recited (e.g. analyzing). Therefore, these limitations are not considered to further limit the method defined by the claims.
Hart does not teach the method wherein the aliquots are injected at an angle of about 45º from one another without fully removing the needle from the skin surface (claim 1).
However, Hart does teach the method for treating or reducing cellulite in a human patient (para 0045), wherein the area affected is typically an area of the skin on the buttocks (para 0020), and a dose of collagenase is injected perpendicular to the patient’s skin (para 0059). Sivagnanam teaches mesotherapy involves the use of multiple injections of compounds by means of very fine needles directly over/near the affected sites (abstract). Mesotherapy is the buzz word in the cosmetic world of “melting fat” for weight loss and cellulite treatment, e.g., removing cellulite in buttocks (p.5 col right – para 3). Collagenase is found to be very effective in the elimination of unwanted fat deposits and skin rejuvenation (p.5 col right – para 4). Common techniques used include injections given at a 45 degree angle from the skin (p.6 col right – para 6). In addition, FDA teaches injecting collagenase wherein approximately one-third of a dose of collagenase is injected, the needle tip is withdrawn and repositioned in a slightly more distal location to the initial injection and inject another one-third of the dose (p.2 last para).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to inject aliquots at an angle of about 45º from one another without fully removing a needle from the skin surface, since Hart discloses a method of treating cellulite in buttocks comprises administering one or a plurality of injections of collagenase to an area affected by EFP, more commonly referred to as cellulite, in a human patient, Sivagnanam and FDA disclose that injection at an angle of about 45º and injection without fully removing a needle from the skin surface, respectively, are commonly used injection techniques for multiple injections of collagenase. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references and routine practice to inject aliquots at an angle of about 45º from one another without fully removing a needle from the skin surface, with a reasonable expectation for successfully treating or reducing cellulite in a human patient.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hart (US 2014/0335072 A1; 11/13/2014.) in view of Sabatino et al (US 7,811,560 B2; 10/12/2010. Cited on IDS), Endo (Endo. 2016;1-7.), Sivagnanam (Journal of Pharmacology and Pharmacotherapeutics. 2010;1(1):4-8.), and FDA (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf. 2017;1-8.) as applied to claims 1-4, 6, 8-9, 11, 15, and 20 above, further in view of Pianez et al (Clin Cosmet Investig Dermatol. 2016;9:183–190.).
References cited above do not teach the injecting is performed with a ½ inch needle (claim 5).
However, Hart does teach the method for treating cellulite in buttocks, wherein injections are administered using a ¼ inch needle (para 0059). Pianez teaches treating cellulite in buttocks (p.183 Background), comprising the use of ½ inch size needle (Figure I).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use a ½ inch size needle, since Hart and Pianez both disclose a method of treating cellulite in buttocks, and Pianez discloses that a ½ inch size needle is used. Therefore, before the effective filing date of the claimed invention, a skill in the art would use a desired needle size to achieve an optimal outcome, since both ¼ inch needle and ½ inch needle are used for treating cellulite. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to use a ½ inch size needle, with a reasonable expectation for successfully treating or reducing cellulite in a human patient.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hart (US 2014/0335072 A1; 11/13/2014.) in view of Sabatino et al (US 7,811,560 B2; 10/12/2010. Cited on IDS), Endo (Endo. 2016;1-7.), Sivagnanam (Journal of Pharmacology and Pharmacotherapeutics. 2010;1(1):4-8.), and FDA (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf. 2017;1-8.) as applied to claims 1-4, 6, 8-9, 11, 15, and 20 above, further in view of Amore et al (Plast Reconstr Surg Glob Open. 2018;6:e1771.).
References cited above do not teach at least one injection occurs at a nadir of one or more dimples (claim 7).
However, Hart does teach the method for treating or reducing cellulite comprises injecting collagenase into cellulite dimples. Amore teaches treating dimpling from cellulite (Title), wherein fibrous septa are mainly at right angles to the skin’s surface, and thickened fibrous septa cause dimpling (a nadir of the dimple) (Fig. 3). The surgical technique of subcision involving mechanical cutting of the retracting hypertrophic septa has revealed itself to be a very effective and lasting way to treat dimpling (p.2 col right – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to make injections at a nadir of a dimple, since Hart and Amore both disclose a method for treating or reducing cellulite dimples, and Amore discloses that thickened fibrous septa cause dimpling (a nadir of the dimple), and that treating fibrous septa improves cellulite dimples. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to make injections at a nadir of a dimple, with a reasonable expectation for successfully treating or reducing cellulite in a human patient.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-4, 6, 8-9, 11, 15, and 20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 8 and 11 of co-pending Application No. 17/259,784 (referred to as the ‘784 application) in view of Hart (US 2014/0335072 A1; 11/13/2014.), Endo (Endo. 2016;1-7.), and Sivagnanam (Journal of Pharmacology and Pharmacotherapeutics. 2010;1(1):4-8.).
Claims 1-3, 8 and 11 of the ‘784 application recite a method of treating cellulite in a thigh of a human patient, comprising the steps of: a. providing a collagenase composition; and b. inserting a needle of a syringe to a skin surface of the thigh and injecting a therapeutically effective amount of the collagenase composition.
Hart teaches a method for treating or reducing edematous fibrosclerotic panniculopathy (EFP), more commonly referred to as cellulite, in a human patient (para 0045) comprising administering to said patient one or a plurality of subdermal injections of collagenase to an area affected by EFP (para 0002, 0004, 0006), the dose of collagenase administered depends on the size of the treatment area, and is thus between about 5 to about 5000 ABC units (a therapeutically effective amount) (para 0005), wherein the area affected by EFP is typically an area of the skin on the buttocks characterized by one or more dimples (para 0020), the collagenase is purified from Clostridium histolyticum, the collagenase comprises collagenase I (AUX-I) and collagenase II (AUX-II) (as described in U.S. Pat. No. 7,811,560 by Sabatino) (para 0024), and the small or trace amount of impurity is less than about 1% by area (para 0028).
Hart teaches the method wherein the collagenase is XIAFLEX®, or CCH (para 0024, Table 3). Endo teaches women with moderate or severe cellulite are treated with a plurality of CCH injections having a therapeutically effective amount on buttocks for up to three treatment sessions (p.1 para 3), primary endpoint is the proportion of composite responders at Day 71 defined as subjects with a 2-point improvement in severity from baseline in the clinician-reported (CR) PCSS and a 2-point improvement in the patient-reported (PR) PCSS, and additional endpoints include a composite of 1-point responders, the percentage of responders with 1-point and 2-point improvements on the CR-PCSS and PR-PCSS (p.1 last para, p.2 first para). Subjects receiving CCH demonstrated a highly statistically significant improvement in the primary endpoint of composite investigators’ and patients’ assessments of the appearance of cellulite, as measured by a two-point improvement in both the CR-PCSS and PR-PCSS, and subjects receiving CCH demonstrated a highly statistically significant improvement in the composite investigators’ and patients’ assessments of the appearance of cellulite, as measured by a one-point improvement in both the CR-PCSS and PR-PCSS (p.2 para 3).
Hart teaches injections are administered using a ¼ inch needle, and a dose of collagenase is injected perpendicular to the patient’s skin to a depth of ¼ inch (para 0059). Hart does not teach said collagenase is administered by a clinician who does rely on a spacer, ruler, paper, or other device for the injecting. The plurality of injections includes at least one injection administered to the center of one dimple, and the sites of injection can be about 1 to about 4 cm from one another, which overlaps with the claimed space between injections (para 0022). If the area affected by EFP includes one dimple, the geometric area of the target area can be about 1 cm2 to about 5 cm2, the area can be roughly rectangular in shape and have a length of about 1 to about 15 cm, and the sites for injection of collagenase can be numbered and spaced within the area affected by EFP such as to allow for even distribution and efficacy of the injected collagenase (para 0021). It is noted that limitations of “wherein the treating results in … following the injecting” in claim 1, “wherein the method improves the appearance of dimples” in claims 2-3, and “the method results in an outcome …” in claim 11 do not recite any additional active method steps, but simply state a characterization or conclusion of the results of process step positively recited (e.g. analyzing). Therefore, these limitations are not considered to further limit the method defined by the claims.
The ‘784 application does not teach the method wherein the aliquots are injected at an angle of about 45º from one another without fully removing the needle from the skin surface (claim 1).
However, the ‘784 application does teach the method comprises inserting a needle of a syringe at about 30º angle to a skin surface and injecting aliquots of collagenase per area to be treated from the syringe without fully removing the needle from the skin surface. Sivagnanam teaches mesotherapy involves the use of multiple injections of compounds by means of very fine needles directly over/near the affected sites (abstract). Mesotherapy is the buzz word in the cosmetic world of “melting fat” for weight loss and cellulite treatment, e.g., removing cellulite in buttocks (p.5 col right – para 3). Common techniques used include injections given at a 45 degree angle from the skin (p.6 col right – para 6).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to inject aliquots at an angle of about 45º from one another without fully removing a needle from the skin surface, since the ‘784 application discloses a method of treating cellulite comprises injecting collagenase at an angle of about 30º from one another without fully removing a needle from the skin surface, and Sivagnanam discloses a method of treating cellulite comprises injecting collagenase at an angle of about 45º. Therefore, a skill in the art would use a desired injection technique since both 30º angle injection and 45º angle injection are used for treating cellulite. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to inject aliquots at an angle of about 45º from one another without fully removing a needle from the skin surface, with a reasonable expectation for successfully treating or reducing cellulite in a human patient.
Claim 5 is provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 8 and 11 of co-pending Application No. 17/259,784 (referred to as the ‘784 application) in view of Hart (US 2014/0335072 A1; 11/13/2014.), Endo (Endo. 2016;1-7.), and Sivagnanam (Journal of Pharmacology and Pharmacotherapeutics. 2010;1(1):4-8.) as applied to claims 1-4, 6, 8-9, 11, 15, and 20 above, further in view of Pianez et al (Clin Cosmet Investig Dermatol. 2016;9:183–190.).
References cited above do not teach the injecting is performed with a ½ inch needle (claim 5).
However, the ‘784 application and Hart do teach the method of treating cellulite, Hart does teach the method wherein injections are administered using a ¼ inch needle (para 0059). Pianez teaches treating cellulite in buttocks (p.183 Background), comprising the use of ½ inch size needle (Figure I).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use a ½ inch size needle, since the ‘784 application and Hart both disclose a method of treating cellulite, Hart and Pianez both disclose a method of treating cellulite in buttocks comprises using a needle, and Pianez discloses that a ½ inch size needle is used. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to use a ½ inch size needle with a reasonable expectation for successfully treating or alleviating cellulite in a human patient in need thereof.
Claim 7 is provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 8 and 11 of co-pending Application No. 17/259,784 (referred to as the ‘784 application) in view of Hart (US 2014/0335072 A1; 11/13/2014.), Endo (Endo. 2016;1-7.), and Sivagnanam (Journal of Pharmacology and Pharmacotherapeutics. 2010;1(1):4-8.) as applied to claims 1-4, 6, 8-9, 11, 15, and 20 above, further in view of Amore et al (Plast Reconstr Surg Glob Open. 2018;6:e1771.).
References cited above do not teach at least one injection occurs at a nadir of one or more dimples (claim 7).
However, the ‘784 application and Hart do teach the method of treating cellulite, Hart does teach the method comprises injecting collagenase into cellulite dimples. Amore teaches treating dimpling from cellulite (Title), wherein fibrous septa are mainly at right angles to the skin’s surface, and thickened fibrous septa cause dimpling (a nadir of the dimple) (Fig. 3). The surgical technique of subcision involving mechanical cutting of the retracting hypertrophic septa has revealed itself to be a very effective and lasting way to treat dimpling (p.2 col right – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to make injections at a nadir of a dimple, since the ‘784 application and Hart both disclose a method of treating cellulite, Hart and Amore both disclose a method of treating cellulite dimples, and Amore discloses that thickened fibrous septa cause dimpling (a nadir of the dimple), and that treating fibrous septa improves cellulite dimples. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to make injections at a nadir of a dimple, with a reasonable expectation for successfully treating or alleviating cellulite in a human patient in need thereof.
This is a provisional obviousness-type double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that Sivagnanam discloses an injection depth of only 2 mm (equivalent to 0.0787 inches) - roughly half of the minimum injection depth specified in the claimed methods - and Ilkhchoui is silent on injection depth.
These arguments are not found persuasive because Hart does teach a dose of collagenase is injected to the patient’s skin to a depth of ¼ inch (para 0059).
Applicant argues that Sivagnanam's teachings would have taught one of ordinary skill in the art away from using mesotherapy to treat cellulite, and that the examiner uses improper hindsight.
These arguments are not found persuasive because “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” (MPEP 2123) Further, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).” (MPEP 2141.02) In the instant case, applicants have not pointed to the specific teachings of the Sivagnanam reference to show that the said reference actually “criticize, discredit or otherwise discourage” injecting collagenase at an angle of about 45º. In fact, Sivagnanam does teach collagenase is very effective in the elimination of unwanted fat deposits and skin rejuvenation (p.5 col right – para 4), and common injection techniques include injections given at a 45 degree angle from the skin (p.6 col right – para 6). In addition, 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).
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759