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 .
Election/Restrictions
As previously set forth: Applicant's election with traverse of Group I in the reply filed on 8/20/25 is acknowledged. The traversal is on the ground(s) that the PHA’s claimed may readily be used in fatty media and have good stability whereas Saettone uses the PHA to absorb sebum. Applicant argues Saettone also does not meet the PHA instantly claimed with the R1 and R2 structures. This is not found persuasive because Saettone does meet the claimed PHA structures. Only one of R1 or R2 is required, as long as there are 2 different ones, e.g. one can use R1 and R1’ and still meet the claim limitations. Saettone discloses formula I of [0032] wherein R1 can be C1-C12 alkyl, thus using both R1=3 and R1=4 is embraced therein, and, meets the limitations of having two different repeating units (both chosen from R2). Further, Saettone also discloses the use of fatty oil solvent phase [0041]. As such these arguments are not persuasive
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of one PHA copolymer, poly(3-hydroxynonanoate-co-undecenoate) containing 5% unsaturation 100% epoxidized, isododecane (closest genus claimed is the branched/linear alkanes of claim 13) in the reply filed on 8/20/25 is acknowledged.
Claims 17, 19, 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/20/25.
Claims 3-5, 11, 15-16, 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/20/25.
Response to Amendment/Arguments
Applicant argues Saettone is not an acceptable film forming composition, as evidenced by US 2023/0293421 and comparative example 5 of 17/794753. Applicant argues Saettone does not disclose PHA copolymers according to the present invention, having R1 nor the substitutions of R1.
The Examiner disagrees. The film forming requirements are not found in claim 1. New Claim 22, that requires the PHA copolymers to be film forming, is not rejected under Saettone given the evidence Applicant cites above. Also Saettone does not disclose using the composition for films. Further, claim 1 is currently worded such that the R1 unit A is optional. As long as 2 different unit B’s are met, the claim is met. Thus, arguments herein are not found persuasive.
Applicant argues Portal is overcome by the submitted translation of the foreign priority and statement of common ownership. Applicant argues likewise that the ODP rejection should be withdrawn because the R1 requirements are not met.
The Examiner agrees in part and withdraws the positions over Portal. However, the ODP rejection stands. The R1 monomer of claim 1 is not required in the claims, it is worded so as to be optional. Thus ODP over ‘336 is continued below.
Applicant argues TD’s have been filed over 17794753 and 17794708 and these ODPs should be removed. Applicant wishes to hold the other ODPs in abeyance and have them withdrawn if the claims are allowable.
The Examiner has removed the ODPs over the applications for which TDs have been filed. In response to applicant’s request to hold in abeyance a response, such as, a terminal disclaimer (TD) to the pending ODP rejection, it is noted that the filing of a TD cannot be held in abeyance since that filing “is necessary for further consideration of the rejection of the claims” as set forth in MPEP 804 (I) (B) (1) quoted below:
“As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated.”
Terminal Disclaimer
The terminal disclaimer filed on 2/13/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 17794753, 17794708 have been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 112
Rejection over Claim 6, and its dependents, 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 is overcome by amendment.
Rejection over Claim 7, and its dependents, 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 is overcome by amendment.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 14, and its dependents, is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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.
The content of claim 14 was amended into claim 1 and thusly fails to further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 6-10, 13-14, 21, 23, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saettone (WO 2018/178899) wherein US 2021/0113450 is used as an equivalent English document.
Elements of this rejection are as previously set forth, reiterated below in its entirety in italics. Regarding the new amendments to claim 1: elements below discuss the oily phase being 50-100% of the base formulation [0040], the PHA being 0.1-30 wt% (abstract), meeting the new requirements. The MW of the PHA may be 10,000-1,000,000 [0037], as further required by claim 23 and claim 24 is drawn to optional R1 and is thusly rejected.
Saettone discloses cosmetic compositions comprising biodegradable polyesters and oily phases (title). The oily phase may be 50-100% of the base formulation (aqueous phase is not required) [0040] and can be fatty acid esters, mineral oils, liquid paraffins and those other oils of [0041-0044] (meeting the claimed fatty medium comprising one or more fatty substances of claim 1, ester oils of claim 13, also embracing the linear/branched alkanes of claim 13, and wt% fatty medium claim 14).
The biodegradable polymer may be polyhydroxyalkanoate (PHA) in the form of particles dispersed in the above oily phase [0030]. The PHA is represented by formula I of [0032]. Therein R1 can be C1-C12 alkyls, C2-C12 alkenyls [0032]. Thus, R1 can be C3, C4, C5, ect. See [0034] wherein copolymers using different repeat units of formula I is embraced. The above embraces having R2 and R2’ (e.g. using R1 to be C3, and, R1 to be C4, as the comonomers meets having two different R2’s). Such renders prima facie obvious the copolymer of claim 1. Alternatively, R1 can be C1-C12 alkyls, C2-C12 alkenyls optionally substituted with halogen (meeting the substitution with halogen of claim 1 and compound 11 of claim 21), hydroxyl (-OH) (meeting the substitution with hydroxyl of claim 1), -CN (meeting R1 of compound 12 of claim 21) and/or -OR wherein R is C1-C4 (meeting the interrupted with one or more heteroatoms O of claim 1). These all meet instantly claimed R1 in light of the optional the above substitutions and/or interruptions above. Thus, choosing one of these R1’s, in combination with a second comonomer of either another (different) R1 and/or R2 is prima facie obvious and also meets the requirements of claim 1.
Though the combinations are picked from a list of possible combinations, it has been held that though a specific embodiment is not taught as preferred makes it no less obvious, also, that the mere fact that a reference suggests a multitude of possible combinations does not in and of itself make any one of those combinations less obvious, see Merck v. Biocraft, 10 USPQ2d 1843 (Fed Cir 1985)
Using those monomers that meet R1 and R2, as above, meet claims 2, 6-7. R1 can be a C6-OH unit (see R1=C1-12 alkyl optionally substituted with -OH [0032], also mentioned above), as required by claim 8 (wherein r=6, u=0, G=H, X=O in claim 8). Elements above meet claims 9-10, 13, 14 and 21 wherein the above formulas at least embrace/meet compounds 11 and 12 of claim 21.
Rejection over Claim(s) 1, 6-10, 13, 14 under 35 U.S.C. 102a1, 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 12257336 (see also the corresponding double patenting rejection below) is overcome by the filing of the English translation of the priority documents and statement of common owners.
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.
Claims 1, 6-10, 13, 14, 22, 23, 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 of U.S. Patent No. 12257336.
Elements of this rejection are as previously set forth, reiterated below in its entirety in italics. Regarding the amendments to claim 1 claim 9 of ‘336 meets such, the remaining being the oil phase. Regarding new claim 22, claim 1 of ‘336 discloses that it is film forming. Claim 8 of ‘336 meets new claim 23 and claim 24 is drawn to the optional unit A and is thusly rejected.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘336 discloses unit A wherein R1 can be 9 and unit B wherein R can be 7, thus meeting the PHA of claim 1 wherein the above monomers meet having two different R2’s. Claim 1 of ‘336 also meets instant claims 6-8, that are optional components, 9, 10 and 13, and, claim 9 of ‘336 meets instant claim 14.
Rejection over Claim 1, 2, 6, 8, 9, 10, 13, 14, 21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 9, 10, 16, 17 of copending Application No. 17794753 (reference application) is overcome by terminal disclaimer.
Rejection over Claims 1, 6-10, 13, 14 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10, 14, 15 of copending Application No. 17794708 (reference application) is overcome by terminal disclaimer.
Claims 1, 6-10, 13, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 40, 41 of copending Application No. 18723248 (reference application).
Elements of this rejection are as previously set forth, reiterated below in italics. Claim 40 of ‘248 meets the wt%, the remaining being the fatty oil, as required by claim 1, claim 24 being drawn to an optional component and thusly rejected
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘248 discloses using fatty medium and meets wherein the PHA can have two different R2 groups, meeting instant claim 1, claims 6-8 are optional and thusly rejected. Claim 1 of ‘248 also meets instant claims 9-10, claim 41 of ‘248 meets instant claim 13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Rejection over Claims 1, 2, 6-10, 13, 21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 18 of copending Application No. 18706694 (reference application) is withdrawn, the new wt% are not claimed in ‘694.
Claims 1, 6-10, 13, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25, 38, 41 of copending Application No. 18723216 (reference application).
Elements of this rejection are as previously set forth, reiterated below in its entirety. Claim 38 of ‘216 meets the new limitations of instant claim 1 and new claim 24 is drawn to an optional component.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 25 of ‘216 discloses using fatty medium and meets wherein the PHA can have two different R2 groups, meeting instant claim 1, claims 6-8 are optional and thusly rejected. Claim 1 of ‘216 also meets instant claims 9-10, claim 41 of ‘216 meets instant claim 13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 6-10, 13, 21, 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 36, 39, 40 of copending Application No. 18723263 (reference application).
Elements of this rejection are as previously set forth, the claim numbers being updated to those amended in the file. Amendments to Claim 1 being met by elements of claim 39 of ‘263 and new claim 23 being drawn to optional components.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 24, 39 of ‘263 meets instant claims 1, 9-10, 21. Claim 25 of ‘263 meets instant claim 2. Claims 6-8, 23 are optional and thusly rejected. Claim 40 of ‘263 meets instant claim 13. Claim 36 of ‘263 meets instant claim 21.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 6-10, 13, 21, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 15, 20 of copending Application No. 18707648 (reference application).
Elements of this rejection are as previously set forth, reiterated below. New elements of instant claim 1 are met by claim 15 of ‘648, new claim 24 is drawn to optional components and is thusly rejected
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘648 meets instant claims 1, 9-10, 21. Claim 2 of ‘648 meets instant claim 2. Claims 6-8 are optional and thusly rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALICIA BLAND/ Primary Examiner, Art Unit 1759
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