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 .
Amendments
Claim 1 now requires the step of administering to be performed by one or more injections into a periorbital soft tissue and/or one or more injections into one or more periorbital fat pads wherein each injection into the one or more periorbital fat pads comprises about 30 Units of the protein having hyaluronidase activity.
Claims 6, 12, and 21 have been canceled.
Claims 7, 13, and 20 have had minor typographic changes.
Claim 16 has had a minor typographic change and requires administering one or more injections and requires each injection into the one or more periorbital fat pads to comprise about 30 Units of the protein having hyaluronidase activity.
Claim Status
Claims 1-5, 7-11, and 13-20 are currently pending.
Claim Objections
Previous objections to the claims
Claims 7, 13, 16, and 20-21 were objected to for minor informalities. Applicant has made the appropriate corrections to claims 7, 13, 16, and 20 and the objections have therefore been withdrawn. Claim 21 has been canceled, rendering the objection moot.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
(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.
(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.
(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.
Previous rejection under 35 U.S.C. § 112(a)
RE: Rejection of claims 1-21 under 35 U.S.C. 112(a) because the specification, while being enabling for treating puffiness by reducing a detectable amount of puffiness with some amounts of administered composition does not reasonably provide enablement for “treating periorbital puffiness” commensurate with the special definition of the term “treating” and with all amounts of administered composition.
Without acquiescing to the merits of the rejection of record, applicant has amended independent claims 1 and 16 to require administration of particular amounts of hyaluronidase activity and to particular regions of the body (the periorbital region). Claims 6, 12, and 21 are canceled, rendering their rejection moot. As discussed in the rejection of record, applicant has demonstrated enablement for reducing the detectable amount of periorbital puffiness when the method comprises administration of 30 Units of hyaluronidase to the periorbital region of the subject. Accordingly, applicant asserts that the amendments are sufficient to overcome the rejection of record.
Applicant’s arguments and the amendments have been fully considered and are sufficient to overcome the rejection of record for claims 16-20 but are not sufficient to overcome the rejection of record for claims 1-11 and 13-15.
Claim 1 limits the one or more injections to “periorbital soft tissue” or “periorbital fat pads” but the amount is only specified when administration is to the periorbital fat pads (“wherein each injection into the one or more periorbital fat pads comprises about 30 Units of the protein having hyaluronidase activity”). The administered amount when the injection is to the “periorbital soft tissue” remains uncapped and for the reasons discussed in the rejection of record and below, the method lacks enablement across its full scope.
For at least this reason, claims 1-11 and 13-15 still lack enablement across their full scope. In order to fully address applicant’s amendments, the rejection of record is withdrawn and a new ground of rejection is made below for claims 1-11 and 13-15.
RE: Rejection of claims 1-15 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, regards as the invention.
Claim 1 was considered to contain indefinite language because it recites the phrase “…fused to a targeting moiety to a periorbital region of the subject” and there are two reasonable interpretations of the phrase. Applicant asserts that “it is clear that the phrase ‘to a periorbital region of the subject’ describes the administration of the composition to the periorbital region of the subject” (Remarks, p. 7, par. 2).
Claim 12 was rejected because it recites the approximation “about”, which is considered to be indefinite. Applicant has not made any arguments with respect to this rejection but has been canceled instead.
Applicant’s response to the rejection under 35 U.S.C. § 112(b) has been fully considered but is not sufficient to overcome the rejection of record.
The examiner maintains that the phrase “fused to a targeting moiety to a periorbital region of the subject” has two reasonable interpretations. And although the examiner acknowledges that the claim now recites particular injection sites (“a periorbital soft tissue and/or…periorbital fat pads”), the meaning of the phrase remains unclear.
Specifically, the reasonable interpretations for “administering a composition that comprises a protein having hyaluronidase activity fused to a targeting moiety to a periorbital region of the subject” could mean:
That the administered composition comprises a protein having hyaluronidase activity fused to a generic targeting moiety and this composition is injected to a periorbital region of the subject; or
That the administered composition comprises a protein having hyaluronidase activity fused to a targeting moiety specific to the periorbital region of the subject.
With respect to the approximation “about”, applicant has not argued the merits of this rejection and has canceled claim 12, rendering the rejection moot.
However, claims 1 and 16 have been amended to contain another indefinite use of this approximation. The phrase “about 30 Units” is similarly considered to be indefinite for the reasons discussed below.
In order to fully address applicant’s amendments, the rejection of record is withdrawn and a new ground of rejection is made below.
New grounds of rejection under 35 U.S.C. § 112
Claims 1-5, 7-11, and 13-15 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating puffiness by reducing a detectable amount of puffiness with some amounts of administered composition does not reasonably provide enablement for “treating periorbital puffiness” commensurate with the special definition of the term “treating” and with all amounts of administered composition.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). MPEP § 2164.04 further states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
With respect to the nature of the invention and the breadth of the claims, applicant’s invention is directed to methods of treating periorbital puffiness in a subject in need thereof. Applicant defines the term “treating” as encompassing at least partially preventing puffiness, inhibiting puffiness, and relieving puffiness ([0073]). Applicant further defines this term as including reducing any detectable amount or eliminating an individual puffiness (Id.). Preventing and inhibiting within the context of puffiness refers to temporary or permanent prevention or inhibition of the onset of a clinical manifestation of the puffiness ([0074]).
The composition administered in claims 1-5, 7-11 and 13-15 is a protein having hyaluronidase activity fused to a targeting moiety to a periorbital region of the subject. When administered to the periorbital soft tissue, the administered amount is not particularly limited, and the claims encompass the administration of any amount of composition (i.e., are not limited to effective amounts).
With respect to the state of the prior art, the closest prior art is Dobak (WO 2008/048770 A1; cited in IDS filed on 02/17/2023). Dobak teaches pharmaceutical compositions, formulations, methods and systems for treating thyroid eye diseases such as Grave’s ophthalmopathy (“GO”) using adrenergic agents and glucocorticosteroids to induce lipolysis and inhibit adipogenesis, which may provide effective reduction of the tissue mass responsible for the clinical signs and symptoms ([0037]). Dobak teaches that the orbit of the eye and the orbital fat accumulations particularly in the setting of GO contain large amounts of glycosaminoglycans which are substantially composed of hyaluronic acid ([0068]). In some situations, it is advantageous to degrade this hyaluronic acid to improve diffusion of the beta-adrenergic agonist and glucocorticosteroid throughout the orbit. In addition, degrading the hyaluronic acid may further reduce the orbital tissue mass and reduce orbital edema thereby improving the proptosis and GO (Id.). Dobak teaches that the composition may be an enzyme such as hyaluronidase (e.g., recombinant hyaluronidase), which degrades hyaluronic acid (Id.).
Frost et al. (WO 2009/128917 A2; hereinafter Frost) teaches compositions comprising hyaluronan degrading enzymes, specifically hyaluronidase, for treating hyaluronan-associated conditions, diseases, and disorders (p. 1, lines 24-27). Exemplary diseases and conditions include edema (p. 9, lines 14-15). Frost teaches that in some cases, the compositions are administered such that they reach interstitium of skin or tissues having accumulated hyaluronan (p. 108, lines 15-17). Frost does not teach any particular amounts of hyaluronidase but teaches a range of about 10 units to 50,000,000 Units or more (p. 16, lines 6-17).
None of the prior art references teach the use of hyaluronidase to prevent or inhibit puffiness, nor do they provide any working examples which experimentally demonstrate the reduction of periorbital puffiness such that a person having ordinary skill in the art could determine effective amounts to achieve the purposes encompassed by applicant’s special definition of the term “treating”.
With respect to the amount of direction provided by the inventor and the existence of working examples, applicant has provided one working example (Example 2; [0197]-[0201]) wherein one 30U HYLENEX® injection was administered to each periorbital fat pad and four injections were administered in the periorbital soft tissues using the same dosage ([0198]). Applicant teaches that each of the four patients involved in this working example exhibited an improvement in the extent of periorbital puffiness within the first 15-60 minutes and exhibited reduction in periorbital puffiness at 6 months with no adverse effects ([0199]). 12 additional patients were treated according to this regimen and each patient reported a reduction in puffiness with a final puffiness of 3-4 on a subjective 1-10 scale with 10 being the observed starting amount of periorbital puffiness and 0 being no puffiness ([0201]). None of applicant’s working examples involve the use of hyaluronidase enzymes fused to a targeting moiety nor do they teach the complete inhibition, treatment, or prevention of periorbital puffiness (endpoints contained within applicant’s special definition of “treating”).
With respect to the level of one of ordinary skill in the art, a person having ordinary skill in the art is a person having an advanced understanding of biomedical sciences and/or cosmetic or therapeutic administration of enzymes.
With respect to the level of predictability and the amount of experimentation needed, as discussed above, the prior art teaches administration of hyaluronidase enzymes to patients for the purpose of reducing hyaluronan. However, none of the prior art references teach the use of hyaluronidase enzymes fused to targeting moieties, nor do they teach the “treatment” (within the breadth of applicant’s special definition) of periorbital puffiness by administering a hyaluronidase enzyme to a periorbital region of the subject. Applicant’s working examples use a hyaluronidase enzyme (HYLENEX®) for reducing the detectable amount of puffiness with multiple 30U injections of said enzyme. Accordingly, there is a low level of predictability as to which amounts of hyaluronidase enzyme can completely treat, inhibit, or prevent periorbital puffiness. Similarly, although applicant has demonstrated that some amounts of hyaluronidase enzyme can reduce the detectable amount of puffiness (a subset of “treating”), there would be undue experimentation required to determine other amounts and treatment regimens which are sufficient to reduce the detectable amount of puffiness as the scope of the claims allow for any amount of enzyme. For example, a person having ordinary skill in the art would be required to perform separate experiments to determine whether 0.1 Units of hyaluronidase enzyme would also be capable of eliciting such an effect. Similarly, because the methods are for reducing puffiness, it is not clear if administration of higher amounts (e.g., 1,000 or 10,000,000 Units of hyaluronidase) would increase rather than decrease puffiness by virtue of administering large amounts of enzyme to the affected area.
Conclusion
Upon consideration of the Wands factors and the evidence as a whole, applicant has demonstrated enablement for reducing the detectable amount of periorbital puffiness when the method comprises administration of particular amounts to the periorbital soft tissue or fat pads of the subject but has not demonstrated enablement for “treating” periorbital puffiness (within the special definition) by administration of any amount to the periorbital soft tissue.
Claims 1-5, 7-11, and 13-20 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, regards as the invention.
Claim 1 recites the phrase “…fused to a targeting moiety to a periorbital region of the subject”. There are two reasonable interpretations of this portion of the claim.
First, the claim could be interpreted to encompass administration of a composition which has a “targeting moiety” which is specific to “a periorbital region of the subject”.
Second, this claim could be interpreted to encompass periorbital region administration of the composition which comprises a generic “targeting moiety”.
In other words, it is unclear if the phrase “…to a periorbital region of the subject” is descriptive of the administration route or the targeting moiety.
In the interest of compact prosecution, the claim has been interpreted under the latter interpretation. This is consistent with applicant’s statement that the phrase describes the administration of the composition to the periorbital region of the subject (Remarks, p. 7, par. 2).
To address this rejection, applicant should amend the claim language such that the metes and bounds of this claim are clearly defined.
For example, if applicant intends the claim to be interpreted under the second interpretation, the claim could be amended to read “wherein the composition is administered to a periorbital region of the subject” or “administering a composition to a periorbital region of the subject which comprises a protein having hyaluronidase activity fused to a targeting moiety.
Claims 2-5, 7-11, and 13-15 are rejected because they depend from claim 1 and therefore inherit the indefinite language contained therein. Although some claims recite particular locations of administration, it is still unclear whether the targeting moiety or the administration location are modified by the phrase “to a periorbital region of the subject”.
Claims 1 and 16 recite the approximation “about”. In determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application (MPEP § 2173.05(b)(II)). Applicant’s specification discusses the use of the word “about” and states “about” includes the exact amount (i.e., “about 5” means “about 5” but also “5”)([0088]). Furthermore, the specification teaches “about” is an approximation that may vary depending upon the desired properties sought to be obtained by the present disclosure ([0222]). Applicant’s specification does not provide any empirical definition for the approximation and does not reasonably provide a way to ascertain the scope of the range “about 30 Units”. For example, does applicant consider 20, 25, 35, or 40 Units to be “about 30 Units”? Or is there some other definite beginning and end to the claimed range?
Because it is not possible to ascertain the meaning of the approximation “about”, the range has been examined for 30 Units.
Claims 2-5, 7-11, 13-15, and 17-20 depend from these claims and do not further clarify the meaning of the approximation.
Claim 7 is 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.
Claim 7 is in improper dependent form because it references a canceled claim. Specifically, claim 6 has been canceled and the limitations therein were incorporated into claim 1. In the interest of compact prosecution, this claim has been examined as if it depends from claim 1.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Previous rejection under 35 U.S.C. § 102
Claim 21 was rejected as anticipated by Dobak. Applicant has canceled this claim, rendering the rejection moot.
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.
Previous rejection under 35 U.S.C. § 103
RE: Rejection of claims 1-15 and 21 under 35 U.S.C. 103 as being unpatentable over Dobak (WO 2008/048770 A1; cited in IDS filed on 02/17/2023) as applied to claim 21 above, and further in view of Frost et al. (WO 2009/128917 A2).
Applicant asserts that the claims have been amended to require administration of one or more injections of a composition comprising about 30 Units of a protein having hyaluronidase function fused to a targeting moiety to a periorbital region of a subject. Applicant argues that neither Dobak nor Frost teach or suggest fusing a protein having hyaluronidase to a targeting moiety or administering said composition to a periorbital region of a subject. Additionally, neither reference teaches administration of “about 30 Units” of said composition.
Applicant’s arguments have been fully considered and are sufficient to overcome the rejection of record.
Dobak and Frost have been fully reconsidered in light of applicant’s amendments and although the examiner maintains that Frost teaches a pegylated hyaluronidase enzyme, which could be reasonably considered to be a “protein having hyaluronidase activity fused to a targeting moiety”, there is no teaching or suggestion which would have led a person having ordinary skill in the art to use such a composition to target periorbital puffiness. This is because Frost teaches pegylation as being useful to target cancer environments (p. 25, lines 19-21) and there is no expectation that such a moiety would be useful for treating periorbital puffiness. Moreover, Frost teaches that the pegylation can “prevent localized uptake” (p. 156, lines 7-8). Thus, it would not be expected that the administration directly to the periorbital area would result in localization of the protein to the periorbital region.
Accordingly, there would have been no motivation to use Frost’s composition in Dobak’s methods, especially in the recited amount.
For at least these reasons, the rejection of record is withdrawn.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Previous double patenting rejections
RE: Rejection of claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,857,213 B1 in view of Frost et al. (WO 2009/128917 A2).
Applicant asserts that Frost neither teaches nor suggests fusing a protein having hyaluronidase to a targeting moiety or administering a composition comprising about 30 Units of that protein to a periorbital region of a subject and therefore does not remedy the deficiencies of ‘213. Applicant’s argument has been fully considered and is sufficient to overcome the rejection of record.
As discussed above, although Frost teaches a pegylated hyaluronidase enzyme, which could be reasonably considered to be a “protein having hyaluronidase activity fused to a targeting moiety”, there is no teaching or suggestion which would have led a person having ordinary skill in the art to use such a composition to target periorbital puffiness. This is because Frost teaches pegylation to target cancer environments (p. 25, lines 19-21) and there is no expectation that such a moiety would be useful for treating periorbital puffiness. Moreover, Frost teaches that the pegylation can “prevent localized uptake” (p. 156, lines 7-8). Thus, it would not be expected that the administration directly to the periorbital area would result in localization of the protein to the periorbital region and there would accordingly be no motivation to make a substitution of the composition of ‘213 with Frost’s composition.
RE: Rejection of claim 21 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,857,213 B1 in view of Dobak (WO 2008/048770 A1; cited in IDS filed on 02/17/2023).
Claim 21 has been canceled, rendering this rejection moot.
RE: Rejection of claims 16-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,103,183 B2.
Applicant asserts that a terminal disclaimer has been provided in order to obviate this rejection. No such disclaimer has been received. Accordingly, the rejection of record must be maintained.
Maintained double patenting rejection
Claims 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,103,183 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Regarding claim 16, claim 1 of ‘183 is directed to a method of treating periorbital puffiness in a subject in need thereof. The method of claim 1 involves the use of the Periorbital Fullness Assessment Scale (see instant specification at [0196] for support). Claim 1 of ‘183 requires administration of a composition comprising a protein having hyaluronidase activity to the periorbital region of the subject if the subject is graded as 0E, 1E, 2E, 3E, or 3E+. Accordingly, the claims overlap in scope. And although the ‘183 claims do not recite any particular amount for administration, a person having ordinary skill in the art could have arrived at the amount of “about 30” Units through routine experimentation.
Regarding claims 17-19, as discussed above, claim 1 of ‘183 requires a hyaluronidase protein. Although the claims of ‘183 do not teach the use of hyaluronidase, recombinant hyaluronidase, or bovine or human hyaluronidase, the claims nevertheless overlap in scope because the previously patent allows for any hyaluronidase protein.
Regarding claim 20, claim 1 of ‘183 teaches that the dermal filled has not been administered.
Conclusion
No claim is allowed.
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 GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GRANT C CURRENS/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651