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
Applicant's election with traverse of Species A (i.e., a single and specific targeting composition as glycolic acid as a skin care agent, albumin as an intermediate release linker, SEQ ID NO: 1 without flanking sequences, SEQ ID NO: 17, or a collagen-binding domain as a targeting moiety, no carrier component, no cell-penetrating peptide, and no transcription-activating peptide where the linkages between the skin care agent and linker and linker and targeting moiety are covalent linkages) in the reply filed on February 13, 2024, is acknowledged. The traversal is on the grounds that Fehr ‘145 does not teach or suggest the preparation or use of a composition comprising the intermediate release linker and the targeting moiety for binding the targeting composition to native collagen fibers (See Applicant’s Response received on 2/13/24, pg. 12). Rather, Fehr ‘145 only discloses keratin-binding peptides and domains but not collagen-binding peptides or domains, or suggests modifying the keratin-binding domains so that they could specifically bind collagen or any domain within collagen (See Applicant’s Response received on 2/13/24, pg. 12-13). Applicants contend that the issue is not the intended use of the composition, but rather the structure of the composition where a composition that is structurally different from the prior art is neither anticipated nor obvious over the prior art when, the prior art does not clearly suggest the structure of the composition to one of ordinary skill in the at (See Applicant’s Response received on 2/13/24, pg. 13). Additionally, Applicants assert that the Examiner has not met the burden for demonstrating the necessity for restriction pursuant to MPEP 803 that requires for restriction both: (1) that the inventions are independent or distinct as claimed; and (2) that there would exist a serious burden on the Examiner if all the claims were examined (See Applicant’s Response received on 2/13/24, pg. 13-14). Moreover, Applicants assert that the species are so closely related that there is no proper basis for requiring such an election pursuant under MPEP 806.03 (See Applicant’s Response received on 2/13/24, pg. 14). Applicants further contend that Applicants do not traverse the Species Election on the grounds of lack of patentable distinctness between the species, but rather on the grounds that the relatedness of the species precludes the requirement for election notwithstanding possible patentable distinctness between the species (See Applicant’s Response received on 2/13/24, pg. 14-15).
This is not found persuasive for the following reasons. In response to Applicant’s argument that Fehr ‘145 does not teach or suggest the structure of the claimed composition, it is found unpersuasive. Pursuant to MPEP 2111, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1).
A review of the structural requirements of the composition of instant claim 1 demonstrates that the structural requirements of the composition are extremely broad. Instead it appears that the scope of claim 1 attempts to rely on functional/intended use limitations to limit the structural requirements. The actual structural requirements recited in claim 1 are a composition comprising (1) an agent, (2) a linker bound to the agent, (3) a moiety bound to the linker, and (4) and optionally a carrier component. In addition to the structural limitations, each structure is to exhibit a functional property and/or intended use; more specifically, the composition is to function as a targeting composition, the agent is intended to be used as a skin care or cosmeceutical agent, the linker is to exhibit the property of being an intermediate release linker, the moiety is intended to be used to target the composition by exhibiting the functional property of binding native collagen fibers, and the carrier component exhibits the property of enhancing delivery to the skin. Each structural limitation of its face, lacks unity of invention a priori because there is no common core structure, sequence, domain shared among each agent, linker, and/or moiety for each structural limitation to function as instantly claimed. For example, the moiety to target native collagen fibers is not defined in the instant specification thereby encompassing proteins, peptides, small molecules, nucleotides, etc.
Notwithstanding the lack of shared structure among each subspecies within Species A (e.g., agent, linker, and moiety), the species lacks unity of invention in light of the teachings of Fehr ‘145. As discussed in the Restriction mailed on 10/2/23, Fehr ‘145 teaches a composition comprising a fusion protein comprising at least one keratin-binding polypeptide and an effector molecule where the two components can be linked via a linker/spacer (See Fehr pg. 59-60). It is acknowledged that Fehr ‘145 does not identify the polypeptides as being capable of binding to native collagen fibers. However, as discussed in the Restriction, since Fehr ‘145 teaches the structural requirement of claim 1, i.e., a moiety, the claimed functional property would inherently be present. Pursuant to MPEP 2112.01(II), “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Thus, given that Fehr ‘145 discloses the claimed structure of the moiety, Fehr ‘145 would also inherently anticipate and/or necessarily render the claimed function obvious as well.
Moreover, pursuant to MPEP 2112.01(I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus, given that Fehr ‘145 anticipates and/or renders the claimed structure of the moiety obvious, the burden is on Applicant to show that the product of the Applicant and the prior art are not the same. Applicants have failed to do so. Rather, Applicants assert that because Fehr ‘145 fail to expressly teach or suggest that the moiety functions as a collagen binding peptide, that the anticipation/obviousness rejection falls. Such an argument is unpersuasive as it does not assert why or how the prior art product is not the same as the claimed product. Therefore, contrary to Applicant’s argument, Fehr ‘145 not expressly teaching or suggestion that the polypeptides bind to collagen, does not preclude that the species lack unity of invention in view of Fehr ‘145.
In response to Applicant’s argument that the Examiner has not met the burden for demonstrating the necessity for restriction pursuant to MPEP 803, it is found unpersuasive. This is not found persuasive because patentable distinction and independence and undue search burden are not criteria for election/restriction purposes under 35 USC §121 and 35 USC § 372. Rather, unity of invention pursuant to 37 C.F.R. §1.475 governs. Please refer MPEP 1850 for details.
In response to Applicant’s argument that the species are so closely related that there is no proper basis for requiring such an election pursuant under MPEP 806.03, it is found unpersuasive. As discussed supra, the structure of the claimed agents, linkers, and moieties are extremely broad thereby encompassing any protein, peptide, nucleic acid, small molecule, large chemical compound, etc. Structurally, the claimed components are not related. There is nothing in the specification or known in the art to suggest that each claimed component shares a common structure, sequence or domain that would function as claimed. Thus, contrary to Applicant’s argument, the claimed species are not structurally related.
Additionally and/or alternatively, the species lack unity of invention in light of the Nimni reference discussed in the 102(a)(1) rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Please note that in light of the Examiner’s search, the agent is expanded to include a skin care or cosmeceutical agent of GM-CSF, a histamine receptor H1 antagonist, H2 antagonist, H3 antagonist, H4 antagonist, a kinin receptor antagonist, and a leukotriene receptor antagonist. Moreover, claim 163 being directed to where the composition further comprising the optional carrier component is hereby rejoined and examined.
Status of Claims
Claims 1-204 were originally filed on March 26, 2021.
The amendment received on March 26, 2021, canceled claims 2-4, 7, 9-11, 13-15, 17-27, 30-31, 33-34, 36-39, 41-46, 48, 50-61, 64-68, 70, 72-73, 75-76, 78-79, 81-82, 84-158, 160-162, and 164-204; and amended claims 6, 16, 29, 63, 69, 83, and 159. The amendment received on September 16, 2024, amended claim 8. The amendment received on June 11, 2025, canceled claims ; and amended claims 1, 5, 49, and 159.
Claims 1, 5-6, 8, 12, 16, 28-29, 32, 35, 40, 47, 49, 62-63, 69, 71, 74, 77, 80, 83, 159, and 163 are currently pending and claims 1, 5, 35, 49, 71, 77, 159, and 163 are under consideration as claims 6, 8, 12, 16, 28-29, 32, 40, 47, 62-63, 69, 74, 80, and 83 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. Applicant timely traversed the restriction (election) requirement in the reply filed on September 16, 2024.
Please note that the claim set received on June 11, 2025, fails to indicate that claims 84-158 and claims 160-162 are canceled. It is respectfully requested that every claim include a status identifier.
Priority
The present application claims status as a 371 (National Stage) of PCT/US2019/052424 filed September 23, 2019, and claims priority under 119(e) to U.S. Provisional Application No. 62/737,579 filed on September 27, 2018.
Sequence Interpretation
For claim 5, please note that the Examiner is interpreting the scope as open-ended requiring 100% identity to (i) SEQ ID NO: 1 with any N- and/or C-terminal additions, or (ii) SEQ ID NO: 2 with any N- and/or C-terminal additions. It is further noted that examination is limited to Applicant’s election of (i).
Response to Arguments
Applicant’s arguments, see Response, filed 6/11/25, with respect to the drawings objection have been fully considered and are persuasive. The objection of Figure 3 has been withdrawn.
Applicant’s arguments, see Response, filed 6/11/25, with respect to the claim objection have been fully considered and are persuasive. The objection of claim 159 has been withdrawn.
Applicant’s arguments, see Response, filed 6/11/25, with respect to the improper Markush grouping rejection have been fully considered and are persuasive. The rejection of claim 159 on the basis that it contains an improper Markush grouping of alternatives has been withdrawn.
Applicant’s arguments, see Response, filed 6/11/25, with respect to the 112(b) rejection have been fully considered and are persuasive. The rejection of claims 1, 5, 35, 49, 71, 77, 159, and 163 as failing to comply with the written description requirement has been withdrawn.
Applicant’s arguments, see Response, filed 6/11/25, with respect to the 112(b) rejection have been fully considered and are persuasive. The rejection of claim 49 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 has been withdrawn.
Applicant’s arguments, see Response, filed 6/11/25, with respect to the 112(b) rejection have been fully considered and are persuasive. The rejection of claim 49 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 has been withdrawn.
Applicant’s arguments, see Response, filed 6/11/25, with respect to the 112(b) rejections have been fully considered and are persuasive. The rejections of claim 159 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 have been withdrawn. NOTE: both 112(b) rejections over claim 159 are withdrawn.
Maintained/Modified Objections
Drawings
The drawings; in particular, Figure 5, is objected to because of the following reason:
The drawings have a line quality that is too light to be reproduced (weight of all lines and letters must be heavy enough to permit adequate reproduction) or text that is illegible (reference characters, sheet numbers, and view numbers must be plain and legible) see 37 CFR 1.84(l) and (p)(1)); See Figure 5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant's arguments filed 6/11/25 have been fully considered but they are not persuasive with respect to Figure 5. Figure 5 is depicted as:
PNG
media_image1.png
528
665
media_image1.png
Greyscale
. Please note that the two bottom arrows point to words that are not legible. The top arrow points to a line that is not legible. As such, Figure 5 still depicts text that is not legible. Thus, the objection of Figure 5 is maintained.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 102
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.
Claims 1, 5, 35, 49, 71, 77, 159, and 163 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nimni et al. WO 2012/112690 A2 published August 23, 2012 (cited in the IDS received on 3/26/21). Please note that the rejection has been updated in light of Applicants’ amendments to claims 1 and 159.
For claims 1, 5, and 159, Nimni et al. claims a target composition comprising (a) a therapeutic agent, (b) an intermediate release linker bound to the therapeutic agent, and (c) a targeting moiety bound to the intermediate release linker, the targeting moiety for binding the targeting composition to native collagen fibers (See Nimni claim 1). As such, Nimni’s component (b) identical to instant component (b) as recited in instant claim 1.
Regarding instant component (a), Nimni et al. also claims where the therapeutic agent is an anti-inflammatory therapeutic agent such as a histamine receptor antagonist selected from the group consisting of histamine receptor H1 antagonists, H2 receptor antagonists, H3 receptor antagonists, H4 receptor antagonists, kinin receptor antagonists, and leukotriene antagonists (See Nimni claims 47-52). Moreover, Nimni et al. claims where the therapeutic agent is a growth factor such as GM-CSF (See Nimni claims 98-100). Pursuant under MPEP 2131.02(I), a species will anticipate a claim to a genus. "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). Furthermore, pursuant under MPEP 2131.02(II), when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). Although Nimni et al. does not expressly claim that these histamine receptor antagonists, GM-CSF, kinin receptor antagonists, and leukotriene antagonists are skin care or cosmeceutical agents, since Nimni et al. claims specific species of skin care or cosmeceutical agents it would then follow that Nimni et al. claims where the therapeutic agent is a skin care or cosmeceutical agent when the therapeutic agent is a histamine receptor antagonist (i.e., H1, H2, H3, or H4), GM-CSF, kinin receptor antagonist, or leukotriene antagonist. Thus, the disclosure of Nimni et al. satisfies the claim limitation with respect to where instant component (a) is a skin care or cosmeceutical agent such as GM-CSF, histamine H1, H2, H3, or H4 antagonist, a kinin receptor antagonist, or a leukotriene antagonist as recited in instant claim 1, and with respect to where the skin care or cosmeceutical agent is a kinin receptor antagonist or leukotriene antagonist as recited in instant claim 159.
Regarding instant component (c), Nimni et al. claims where the targeting moiety is selected from the group consisting of (i) SEQ ID NO: 1, (ii) SEQ ID NO: 2, and (iii) peptides related to (i) or (ii) by one or more conservative amino acid substitutions (See Nimni claim 2). When comparing Nimni’s SEQ ID NO: 1 with instant SEQ ID NO: 1, there is 100% identity. Thus, the disclosure of Nimni et al. satisfies the claim limitation with respect to where the targeting moiety comprises a protein or peptide as recited in instant claim 1 and where the targeting moiety is SEQ ID NO: 1 as recited in instant claim 5.
For claims 1 and 163, regarding the carrier component, it is noted that claim 1 does not require a carrier component, but rather is optional. As such, for claim 1, it is unnecessary for Nimni et al. to expressly disclose a carrier component. Nonetheless, Nimni et al. claims a pharmaceutical composition comprising a therapeutically effective quantity of at least one targeting composition of claim 1, and a pharmaceutically acceptable carrier, diluent, or excipient in unit dosage form (See Nimni claim 107). Moreover, Nimni et al. discloses that pharmaceutically acceptable carriers include solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents (See Nimni, [0210]). The pharmaceutically acceptable carrier should be suitable for various routes of administrations (See Nimni, [0210]). Formulations for parenteral administration include excipients such as sterile water or saline (See Nimni, [0213], [0218]). Formulations for inhalation include excipients such as lactose and aqueous solutions (See Nimni, [0213]).
Although Nimni et al. does not expressly disclose that the carrier is suitable for application to the skin, the carrier/excipient disclosed by Nimni (i.e., sterile water, saline, aqueous solutions) encompasses carriers/excipients that are suitable for application to the skin. Pursuant to MPEP 2111.04(I), [c]laim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The court has found that the determination of whether clauses such as “wherein” and “whereby" is a limitation in a claim is dependent on the specific facts of the case. If the “wherein" or “whereby” clause limits a process claim where the clause gives meaning and purpose to the manipulative steps, it should be given patentable weight. Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002). However, the court also found (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” In the instant case, the carrier component is intended to be suitable for application to the skin thereby constituting the intended use of the carrier component, and thus, the structure imparted by such a use would be one requiring the carrier/excipient to be in a form capable of application to the skin. Since Nimni et al. discloses carriers/excipients suitable for application to the skin, the structural limitation imparted by the “wherein” clause is met. Thus, the disclosure of Nimni et al. satisfies the claim limitation with respect to where the targeting composition optionally contain a carrier component where the carrier component is suitable for application to the skin and is a pharmaceutically acceptable carrier, diluent, or excipient as recited in instant claims 1 and 163.
Regarding the carrier component enhancing delivery to the skin, since Nimni et al. claims a carrier component thereby satisfying the necessary structural limitation as instantly claimed, the functional property (i.e., enhancing delivery to the skin) of the carrier component as claimed and the known carrier component are inherently the same. The discovery of a previously unappreciated property of a prior art composition, or a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of new structural properties (i.e., enhancing delivery to the skin) which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 4333 (CCPA 1977). Thus, the disclosure of Nimni et al. satisfies the claim limitation with respect to where the carrier component enhances delivery to the skin as recited in instant claim 1.
For claim 35, Nimni et al. claims where the intermediate release linker is stabilized by crosslinking (See Nimni claim 31). Thus, the disclosure of Nimni et al. satisfies the claim limitation with respect to where the intermediate release linker is stabilized by crosslinking as recited in instant claim 35.
For claim 49, Nimni et al. claims where the intermediate release linker is a polymer that shields the therapeutic agent of the composition from clearance by macrophages (See Nimni claim 59). Nimni et al. also claims where the polymer is albumin (See Nimni claims 60-63). Thus, the disclosure of Nimni et al. satisfies the claim limitation with respect to where the intermediate release linker is a polymer that shields the skin care or cosmeceutical agent of the composition from clearance by macrophages as recited in instant claim 49, and with respect to the Applicant’s elected intermediate release linker being albumin.
For claim 71, Nimni et al. claims that the linkage between the therapeutic agent and the intermediate release linker is a covalent linkage (See Nimni claim 81). Thus, the disclosure of Nimni et al. satisfies the claim limitation with respect to where the linkage between the therapeutic agent and the intermediate release linker is a covalent linkage as recited in instant claim 71.
For claim 77, Nimni et al. claims where the linkage between the intermediate release linker and the targeting moiety is a covalent linkage (See Nimni claim 87). Thus, the disclosure of Nimni et al. satisfies the claim limitation with respect to where the linkage between the intermediate release linker and the targeting moiety is a covalent linkage as recited in instant claim 77.
Accordingly, the disclosure of Nimni et al. anticipates instant claims 1, 5, 35, 49, 71, 77, 159, and 163.
Applicants’ Arguments
Applicants contend that the claimed invention is not anticipated by Nimni because (1) Nimni fails to disclose using collagen-binding domains to deliver skin care agents or cosmeceutical agents, but rather solely for therapeutic applications, particularly for the treatment of cancer (See Applicant’s Response received on 6/11/25, pg. 61); (2) Nimni fails to provide an enabling disclosure, in particular, enabled for topical delivery so that the agent is delivered in a sufficient quantity to the epithelium of the subject seeking cosmetic improvement given that topical delivery would be ineffective because the tissue, organ or organ system to be treated is other than the epithelium (See Applicant’s Response received on 6/11/25, pg. 61); (3) Nimni fails to disclose suitable methods for binding the skin care or cosmeceutical agents to the collagen-binding domains for delivery to the skin because there must be substantial guidance with respect to methods for binding the skin care or cosmeceutical agents to the collagen-binding domains so that delivery is efficient to the epithelium while retaining the skin care or cosmeceutical activity of the agent (See Applicant’s Response received on 6/11/25, pg. 62); (4) Nimni discloses an extremely broad genus of additional components other than the collagen-binding domains and the targeted release linker that have physiological or pharmacological activity with no guidance with respect to which, if any, are suitable for the instant compositions or with respect to individual species or a limited subgenus (See Applicant’s Response received on 6/11/25, pg. 63); (5) any difference in the properties or utilities between the genus described in the prior art and the claimed invention needs to be taken into account (See Applicant’s Response received on 6/11/25, pg. 64); (6) the case law cited in the rejection supporting a general rule that a species anticipates a genus cannot be read to support the converse proposition that a generic disclosure in the prior art would anticipate or make obvious a species (See Applicant’s Response received on 6/11/25, pg. 64); (7) the reliance of In re Best is misplaced because the decision is inapplicable given that the methods of the present invention require further information regarding the actual capability of the agents to function as instantly claimed and a considerable degree of experimentation and selection would be required to select suitable agents, suitable intermediate release linkers and collagen-binding domains (See Applicant’s Response received on 6/11/25, pg. 64-65); (8) the function of the claimed invention must be taken into account in light of the case: Union Oil of California v Atlantic Richfield Co. (See Applicant’s Response received on 6/11/25, pg. 65); and (9) the reliance of Atlas Powder in misplaced because there must be a determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art, which is not the case with Nimni (See Applicant’s Response received on 6/11/25, pg. 65-66).
Response to Arguments
Applicant's arguments filed 6/11/25 have been fully considered but they are not persuasive for the following reasons.
It is noted that Applicants’ arguments appear to primarily focus on the intended use/functional property of the composition being a targeting composition, the agent being a skin care or cosmeceutical agent, the moiety being a targeting moiety for binding to native collagen fibers, and the optional carrier component enhancing delivery to the skin and is suitable for application to the skin. Thus, the Examiner will address Applicants’ arguments as they pertain to the intended use/functional properties of the composition, the agent, moiety, and carrier as instantly claimed.
Pursuant to MPEP 2131, "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987) (emphasis added). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001). "The identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990). In the instant case, it is noted that the claimed invention is directed to a composition of matter, i.e., a product. The structural limitations of independent claim 1 are: (1) a composition comprising (2) an agent, (3) a linker bound to the agent, (4) a moiety bound to the linker wherein the moiety comprises a protein or peptide, and (5) optionally, a carrier component. Given that the carrier component is optional, it is not a required structural limitation of the claimed composition. With respect to the claimed structural limitations, as discussed in the rejection supra, Nimni et al. expressly claims:
1. A targeting composition comprising:
(a) a therapeutic agent;
(b) an intermediate release linker bound to the therapeutic agent; and
(c) a targeting moiety bound to the intermediate release linker, the targeting moiety for binding the targeting composition to native collagen fibers.
2. The targeting composition of claim 1 wherein the targeting moiety is selected from the group consisting of: (i) Trp-Arg-Glu-Pro-Ser-Phe-Met-Ala-Leu-Ser (WREPSFMALS) (SEQ ID NO: 1); (ii) Trp-Arg-Glu-Pro-Ser-Phe-Cys-Ala-Leu-Ser (WREPSFCALS) (SEQ ID NO: 2); and (iii) peptides related to (i) or (ii) by one or more conservative amino acid substitutions.
47. The targeting composition of claim 1 wherein the therapeutic agent is an anti-inflammatory therapeutic agent.
48. The targeting composition of claim 47 wherein the anti-inflammatory therapeutic agent is a histamine receptor antagonist selected from the group consisting of histamine receptor H1 antagonists, histamine receptor H2 antagonists, histamine receptor H3 antagonists, and histamine receptor H4 antagonists.
49. The targeting composition of claim 48 wherein the anti-inflammatory therapeutic agent is a kinin receptor antagonist.
50. The targeting composition of claim 49 wherein the kinin receptor antagonist is a kinin receptor antagonist selected from the group consisting of B1 and B2 receptor antagonists.
51. The targeting composition of claim 47 wherein the anti-inflammatory therapeutic agent is a leukotriene receptor antagonist.
98. The targeting composition of claim 1 wherein the therapeutic agent is a growth factor.
100. The targeting composition of claim 99 wherein the growth factor is
GM-CSF.
As discussed in the rejection supra, instant SEQ ID NO: 1 is 100% identical to Nimni’s SEQ ID NO: 1 thereby constituting a moiety comprising a peptide as recited in instant claim 1(c). As such, Nimni expressly discloses specific claimed embodiments satisfying each of the instant required structural limitations of (1), (2), (3), and (4). Thus, Nimni’s disclosure anticipates the instant required structural limitations as the identical invention is expressly claimed in as complete detail as is contained in the instant claim.
Regarding the composition being a targeting composition, Nimni’s composition expressly exhibits the intended use/function of being a targeting composition. Similarly, Nimni’s linker expressly exhibits the function of being an intermediate release linker. Moreover, Nimni’s moiety expressly exhibits the intended uses/functions of being a targeting moiety and for binding the targeting composition to native collagen fibers. Therefore, Nimni’s claimed composition expressly discloses the instantly claimed intended uses/functions of the composition, linker and moiety. Thus, Nimni’s claimed components of the composition are identical to the instantly claimed required components of the composition except for the agent of structural limitation (1) exhibiting the intended use/function of being a skin care or cosmeceutical agent.
Regarding the agent being a skin care or cosmeceutical agent, as discussed in the rejection supra, pursuant under MPEP 2131.02(I), a species will anticipate a claim to a genus. "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). Furthermore, pursuant under MPEP 2131.02(II), when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). In the instant case, and as indicated supra, Nimni expressly claims where the agent is an anti-inflammatory agent, in particular, a histamine receptor antagonist, a kinin receptor antagonist, or a leukotriene receptor antagonist. Alternatively, the agent is a growth factor, in particular, GM-CSF. Since instant claim 159 encompasses where the skin care or cosmeceutical agent is a kinin receptor antagonist or a leukotriene receptor antagonist, which are species of Nimni’s therapeutic agent and are species of the instant skin care or cosmeceutical agent, it must follow that these specific species of agents anticipate the instant agent being a skin care or cosmeceutical agent. As such, contrary to Applicant’s argument, the Office does not utilize a genus to anticipate a species.
Similarly, GM-CSF is well known to function as a cosmeceutical agent as evidenced by WO 2008/116116 A2, and histamine receptor antagonists are well known to function as skin care agents as evidenced by Ashida et al., J. Invest. Dermatol. 116:261-265 (2001). ‘116 teaches that GM-CSF promotes migration of activated (but not differentiating) keratinocytes to wound sites and increases the quantity and improves the quality of collagen (See ‘116, abstract). As such, GM-CSF reversed skin impairment in multiple animal models thereby demonstrating efficacy in cosmetic applications (See ‘116, abstract). Ashida et al. teaches that the H1 and H2 receptor antagonists accelerated the recovery of skin barrier function (See Ashida, abstract). Thus, Nimni disclosing H1 and H2 receptor antagonists and GM-CSF as specific species of therapeutic agents necessarily constitute agents that exhibit the intended use/function of being a skin care or cosmeceutical agent.
Furthermore, although Nimni teaches a large number of potential therapeutic agents, Nimni’s claim 47 is directly dependent upon claim 1, i.e., the independent claim directed to the targeting composition, and claims 48-51 are dependent upon claim 47 as being species of anti-inflammatory agents. Similarly, Nimni’s claim 98 is directly dependent upon claim 1 and claim 100 is dependent upon claim 98 as being a specific species of growth factor. As such, these dependent claims represent specific embodiments that an ordinary skilled artisan would at once envisage. Pursuant to MPEP 2131.02, it states that, “[i]f one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be "at once envisaged." One may look to the preferred embodiments to determine which compounds can be anticipated.” In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962). In other words, Nimni’s claim 48 encompasses the limitations of Nimni’s claim 1 where the therapeutic agent is a H1, H2, H3 or H4 receptor antagonist thereby constituting a specific embodiment that an ordinary skilled artisan would at once envisage.
Additionally, with respect to whether a prior art reference is required to teach an intended use of function of a composition/product claim, as discussed supra, the only required intended use/function in claim 1 relating to topical or skin application is the agent being a skin care or cosmeceutical agent. The intended use/functional language recited in claim 1 that relates to topical or skin application is associated with the carrier component, which is optional. However, as will be further articulated below, even if the intended use/functional language associated with the carrier component is required, Nimni’s disclosure would still anticipate the instant composition. As such, as currently recited, the composition encompasses any intended means of administration. Even still, skin care or cosmeceutical agents are not limited to topical application. Morgado-Carrasco et al. teaches that oral hydrolyzed collagen and oral hyaluronic acid are well tolerated and numerous clinical trials show they can mitigate some signs of skin aging (See Morgado-Carrasco et al., ACTAS Dermo-Sifiliograficas 114:T114-T124 (2023) at abstract; pg. T116, col. 1, last paragraph to col. 2, last paragraph; pg. T118, col. 1, 2nd paragraph to last paragraph; Tables 3-4). Moreover, Morgado-Carrasco et al. teaches that isotretinoin is a retinoid widely used in the treatment of acne and many other skin conditions, which can be administered orally (See Morgado-Carrasco, pg. T116, col. 1, 1st paragraph; Table 2). The plasmin inhibitor tranexamic acid (TA) is a potent anti-inflammatory and depigmenting agent that is administered orally in the treatment of melasma, and has shown a reduction in wrinkles, and skin and photoaging signs (See Morgado-Carrasco, pg. T118, col. 2, 1st to 3rd paragraph). As such, skin care or cosmeceutical agents can also be administered orally and are not limited to topical application to the skin. Therefore, each of the intended uses/functional properties associated with required structural components of the composition are expressly and/or inherently taught by Nimni’s teachings.
Additionally, even if the claimed composition is directed to topical or skin application, for example, in the preamble, Nimni’s disclosure would still anticipate the claimed composition. Although it is acknowledged that Nimni et al. does not expressly disclose that the composition is administered topically or applied to the skin, Applicant is respectfully reminded that the claimed invention is directed to a product and not a method of using the product. Pursuant to MPEP 2111.02(II),
[i]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation).
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) (emphasis added).
In the instant case, as discussed in the rejection supra, Nimni expressly discloses the structure of the instant composition. As such, the disclosure of Nimni anticipates the claimed structural limitations of the claimed invention, i.e., a composition comprising an agent, a linker bound to the agent, and a moiety bound to the linker and comprising a peptide or protein, for the reasons set forth in the rejection supra.
The remaining claim limitations, i.e., (1) the composition being a targeting composition, (2) the agent functions as a skin care or cosmeceutical agent, (3) the linker being an intermediate release linker, (4) the moiety being a targeting moiety for binding the composition to native collagen fibers, and (5) the carrier enhancing delivery to the skin and is suitable for application to the skin (presuming the carrier becomes a required structural limitation and/or the composition is amended to be applied topically to the skin), all constitute functional properties and/or intended uses of a structural component of the composition. In light of the MPEP, the question is whether these functional/intended use limitations impart structure to the claimed structural components of the instant composition. As discussed supra, Nimni expressly claims a composition comprising each of the required structural limitations. Therefore, the structure imparted from the claimed intended use/functional property limitations of (1), (3) and (4) limitations are taught by the prior art since these intended use/functional property limitations do not impart a structural limitation for one of claimed structural limitations, and thus, are of no structural significance in determining whether Nimni anticipates the claimed invention. However, intended use/functional property limitations of (2) and (5) (note: presuming the carrier is amended to be a required structural limitation), may impart structure to the agent and carrier, respectively. As discussed in the MPEP supra, the question is whether a prior art structure is capable of performing the intended use/functional property. More specifically, an agent must be capable of functioning as a skin care or cosmeceutical agent, and the carrier must be capable of enhancing delivery to the skin and be in a form suitable for application to the skin. The agent being capable of functioning as a skin care or cosmeceutical agent is addressed supra. Moreover, as discussed in the rejection supra, Nimni expressly discloses that the carrier can be sterile water, saline, or aqueous solutions; all of which are suitable forms of carriers for application to the skin. By the carrier component being in a form suitable for application to the skin, and being that the claimed carrier structure is not limited, i.e., any carrier structure as long as it is capable for application to the skin, would inherently exhibit the function of enhancement of delivery to the skin. Therefore, in light of Nimni’s disclosure anticipating the structural components of the claimed composition, it would then follow that Nimni’s composition is capable of performing the claimed functional properties/intended uses.
Additionally and/or alternatively, pursuant to MPEP 2112(I),
the claiming of a new use, new function or unknown property which is necessarily present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The discovery of a previously unappreciated property of a prior art composition, or a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Moreover, pursuant to MPEP 2112.01(I),
where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Pursuant to MPEP 2112.01(II), “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. In the instant case, as discussed supra, Nimni anticipates the claimed structural limitations of the composition. Thus, given that Nimni’s disclosure anticipates the claimed structure of the composition, Nimni’s disclosure would also necessarily anticipate the claimed functions/intended uses. Therefore, contrary to Applicant’s argument, it is unnecessary for Nimni to expressly disclose the claimed functional properties/intended uses of the composition.
In response to Applicant’s argument regarding that Nimni fails to provide an enabling disclosure, in particular, enabled for topical delivery so that the agent is delivered in a sufficient quantity to the epithelium of the subject seeking cosmetic improvement given that topical delivery would be ineffective because the tissue, organ or organ system to be treated is other than the epithelium, it is found unpersuasive. Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969). In the instant case, as discussed supra, Nimni’s disclosure anticipates the instant composition. As such, there is a presumption that the Nimni disclosure is enabled to make and use the claimed composition. Furthermore, there is no requirement that Nimni reduce-to-practice applying the composition to skin, especially given that the composition does not require such a limitation, and even if the composition is required to be applied to skin topically, such a limitation only imparts structure to the claimed composition by requiring the composition to be in a form capable of application to the skin. Simply because Nimni discloses systemic administration or other forms of administering does not per se render the Nimni disclosure as non-enabled for topical administration to the skin.
Additionally, it is noted that the features upon which applicant relies (i.e., topical delivery so that the agent is delivered in a sufficient quantity to the epithelium of the subject seeking cosmetic improvement) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the instant case, as discussed supra, the scope of claim 1 only encompasses application to the skin as associated with the carrier component, which is optional. Moreover, claim 1 does not encompass any amount of any component. As such, the scope of claim 1 does not require the features that Applicant asserts render Nimni not enabled. Therefore, contrary to Applicant’s argument, the Nimni reference enables an ordinary skilled artisan to make and use the claimed composition.
In response to Applicants’ arguments that the case law of In re Best and Atlas Powder are not applicable to the instant claimed invention, it is found unpersuasive. Regarding In re Best, it is noted that Applicant states “[t]his decision is inapplicable because the methods of the present invention require further information regarding the actual capability of the agents recited in Nimni et al.” (See Response, pg. 64, last paragraph) (emphasis added). As stated supra, the claimed invention is directed to a composition of matter, not a method of use. As such, Applicant’s reason as to why the In re Best decision is not applicable to the instant invention is misplaced. Furthermore, as stated supra, an ordinary skilled artisan would not need to select a suitable agent, suitable linker, and suitable targeting moiety as suggested by Applicants because Nimni expressly claims specific embodiments of targeting compositions that contain these components. As such, a considerable degree of experimentation is unnecessary because Nimni expressly claims specific embodiments of targeting compositions that anticipate the required structural components of the compositions. Therefore, contrary to Applicant’s argument the holding of In re Best is correctly applied as discussed in the rejection supra.
Regarding Atlas Powder, it is acknowledged that the Federal Circuit’s standard for inherency is based upon if the prior art necessarily functioned in accordance with or includes the claimed limitations, and that the prior art must necessarily function in accordance with the claimed limitations, which is consistent with the general requirement for inherency that there must be a determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art. However, contrary to Applicant’s argument, as discussed supra, Nimni expressly claims specific embodiments where the therapeutic agent is a histamine receptor antagonist, a kinin receptor antagonist, or a leukotriene receptor antagonist. As such, since Nimni expressly claims specific embodiments that are species of a skin care or cosmeceutical agent, the inherent characteristic of functioning as a skin care or cosmeceutical agent necessarily flows from the teachings of Nimni. Moreover, regarding the linkers, Nimni expressly claims the identical linker as instantly claimed. There is no required structural distinction because Nimni’s linker and the instant linker. Similarly, Nimni’s targeting moieties are identical to the instant targeting moieties. Therefore, contrary to Applicant’s argument, the holding of Atlas Powder is correctly applied as discussed in the rejection supra.
In response to Applicant’s argument that the function of the claimed invention must be taken into account in light of the holding in Union Oil of California v Atlantic Richfield Co. (hereinafter referred to “Union Oil”), it is found unpersuasive. Although the MPEP only refers to Union Oil with respect to written description, it is noted that the facts of Union Oil is distinguishable from the instant invention and Nimni. In particular, gasoline for automotives was found by the Federal Circuit to be distinctive from gasoline for aviation and racing fuels, especially when considering the physical properties claimed in the patented claims in Union Oil. Treatment of skin, even if claimed in the instant composition, is a species of the treatment disclosed in Nimni. Although Nimni discloses a large number of therapeutic agents, as discussed supra, Nimni claims specific embodiments where the therapeutic agent is a histamine receptor antagonist, a kinin receptor antagonist, or a leukotriene receptor antagonist, which are also species of skin care or cosmeceutical agents. As such, the prior art reference utilized in the instant rejection does provide specific embodiments that would be useful for the treatment of the skin thereby distinguishing the fact pattern in the instant case with that described in Union Oil. Similarly, as discussed supra, the claimed targeting moieties are identical structurally and functionally, i.e., to bind to native collagen fibers, to the targeting moieties disclosed by Nimni. Therefore, contrary to Applicant’s argument, the claimed function is considered in the rejection and addressed to the extent necessary as discussed supra, but the holding in Union Oil is not applicable to the instant case for the reasons set forth supra.
Accordingly, the rejection of claims 1, 5, 35, 49, 71, 77, 159, and 163 is maintained as Applicants’ amendments are found unpersuasive.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claims 1 and 159 are rejected under 35 U.S.C. 103 as being unpatentable over Nimni et al. WO 2012/112690 A2 published August 23, 2012 (cited in the IDS received on 3/26/21), as applied to claims 1 and 159 above, and further in view of Steiner et al., Chemical and Physical Peelings, Clinical Approaches and Procedures in Cosmetic Dermatology, Issa et al., eds., Springer Intl. Publishing AG, 10 pages (2016), as applied to Applicant’s election species of skin care agent in claim 159, alone or as evidenced by, Merriam-Webster, “Therapeutic,” Merriam-Webster, available online at https://www.merriam-webster.com/dictionary/therapeutic, 10 pages (accessed on 3/5/25) (hereinafter Merriam-Webster reference), and Merriam-Webster, “Cosmeceutical,” Merriam-Webster, available online at https://www.merriam-webster.com/dictionary/cosmeceutical, 7 pages (accessed on 3/5/25) (hereinafter Merriam-Webster reference 2).
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
For claims 1 and 159, please see discussion of Nimni et al. supra.
For claim 159, with respect to where the agent is glycolic acid as a cosmeceutical agent:
As discussed supra, Nimni et al. teaches that the therapeutic agent can be an anti-inflammatory agent such as a H1 receptor antagonist, a H2 receptor antagonist, a H3 receptor antagonist, a H4 receptor antagonist, a kinin receptor antagonist, or a leukotriene receptor antagonist. Alternatively, the therapeutic agent can be a growth factor such as GM-CSF. However, Nimni et al. does not expressly teach where the therapeutic agent is glycolic acid as elected by Applicants.
Nimni et al. does not define what is meant by a therapeutic agent. Similarly, the instant specification does not define what constitutes a cosmeceutical agent. As such, the plain and ordinary meaning of the terms apply. Therapeutic is defined as relating to the treatment of disease or disorders by remedial agents or methods (See Merriam-Webster reference, pg. 1). Cosmeceutical is defined as a cosmetic preparation that has pharmaceutical properties (See Merriam-Webster reference 2, pg. 1). Thus, a cosmeceutical agent is a subgenus of therapeutic agent.
Steiner et al. teaches that the glycolic acid (GA) peel is the most used alpha hydroxy acid peel, producing a very superficial, superficial, or even a medium-depth peel, all of them usually well tolerated by patients and without systemic toxicity (See Steiner article, pg. 1, col. 2, 1st paragraph). GA peels have been used as an adjunctive therapy in a variety of skin disorders because of its anti-inflammatory, keratolytic, and antioxidant effects (See Steiner article, pg. 1, col. 2, 1st paragraph). Acne (inflammatory and non-inflammatory), acne scars, melasma, photoaging, and post-inflammatory hyperpigmentation can be treated with GA peel but the most common indication has been skin rejuvenation (See Steiner article, pg. 1, col. 2, 1st paragraph). Steiner et al. also teaches that glycolic acid can be used in combination with 5-fluorouracil for the treatment of pre-skin cancer conditions such as actinic keratosis and actinic ceilitis as a so-called fluorouracil-hydroxy pulse peel (See Steiner article, pg. 4, col. 2, 2nd paragraph). Moreover, Steiner et al. teaches that glycolic acid is effective in treating non-inflammatory acne and inflammatory acne because of its antibactericidal effects and antioxidant action by causing epidermolysis, dispersing basal layer melanin and epidermal dermal hyaluronic acid, and correcting altered keratinization (See Steiner article, pg. 5, col. 1, last paragraph). As such, glycolic acid constitutes a cosmeceutical agent that exhibits pharmaceutical properties of being anti-inflammatory and antioxidant thereby also constituting a therapeutic agent. Thus, an ordinary skilled artisan would be motivated to substitute glycolic acid as the anti-inflammatory therapeutic agent of Nimni et al. as further articulated below.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.012)
Nimni et al. does not expressly teach where the agent is glycolic acid as recited in instant claim 159 and as elected by Applicants. However, the teachings of Steiner et al. cure this deficiency by constituting a simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-4143)
With respect to where the agent is glycolic acid as recited in instant claim 159 and as elected by Applicants, it would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to modify the teachings of Nimni et al. and substitute glycolic acid as the anti-inflammatory therapeutic agent instead of a H1 receptor antagonist, a H2 receptor antagonist, a H3 receptor antagonist, a H4 receptor antagonist, a kinin receptor antagonist, or a leukotriene receptor antagonist in a targeting composition comprising the glycolic acid, albumin as an intermediate release linker bound to the glycolic acid, and SEQ ID NO: 1 as a targeting moiety bound to the albumin in order to treat a variety of skin disorders such as acne (inflammatory and non-inflammatory), acne scars, melasma, photoaging, post-inflammatory hyperpigmentation, and skin rejuvenation. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because glycolic acid was known to be the most used alpha hydroxy acid peel, was known to exhibit anti-inflammatory, keratolytic, and antioxidant effects useful to treat acne (inflammatory and non-inflammatory), acne scars, melasma, photoaging, post-inflammatory hyperpigmentation, and skin rejuvenation as taught by Steiner et al. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the targeting composition of Nimni et al. comprised an anti-inflammatory therapeutic agent such as a H1, H2, H3 or H4 receptor antagonist, a kinin receptor antagonist, or a leukotriene receptor antagonist, albumin as an intermediate release linker bound to the therapeutic agent, and SEQ ID NO: 1 as a targeting moiety bound to the intermediate release linker, and therefore, substituting glycolic acid as the anti-inflammatory therapeutic agent instead of the histamine receptor antagonist, the kinin receptor antagonist, or the leukotriene receptor antagonist would support the treatment of acne (inflammatory and non-inflammatory), acne scars, melasma, photoaging, post-inflammatory hyperpigmentation, and skin rejuvenation by constituting a simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicants’ Arguments
Applicants contend that the claimed invention is nonobvious because (1) Steiner does not remedy the deficiencies of Nimni as stated supra (See Applicant’s Response received on 6/11/25, pg. 73); (2) Steiner fails to suggest the use of such alpha-hydroxy acids as a component of a targeting composition and does not provide any guidance with respect to the preparation of such a targeting composition including, along with a collagen-binding domain and an intermediate release linker, an alpha-hydroxy acid, and thus, an ordinary skilled artisan would not be motivated to combine Steiner with Nimni (See Applicant’s Response received on 6/11/25, pg. 73-74); (3) there is an overall lack of guidance required for an ordinary skilled artisan to combine Steiner and Nimni to result in the claimed invention without requiring undue experimentation (See Applicant’s Response received on 6/11/25, pg. 74); (4) an ordinary skilled artisan would not have a reasonable expectation of success given the necessity of selecting suitable linkers and collagen-binding domains to provide delivery of the skin care agent or cosmeceutical to the skin in sufficient quantity to produce the desired esthetic result (See Applicant’s Response received on 6/11/25, pg. 75); and (5) the lead compound analysis renders the claimed invention nonobvious (See Applicant’s Response received on 6/11/25, pg. 75); and (6) the In re Opprecht and In re Bode decisions cited in the 103 rejection introduction do not support the rejection (See Applicant’s Response received on 6/11/25, pg. 75-76).
Response to Arguments
Applicant's arguments filed 6/11/25 have been fully considered but they are not persuasive for the following reasons.
It is noted that Applicant’s first argument is unpersuasive since Applicants’ arguments regarding the Nimni reference are found unpersuasive for the reasons stated forth supra.
In response to Applicant’s second argument, i.e., Steiner fails to suggest the use of such alpha-hydroxy acids as a component of a targeting composition and does not provide any guidance with respect to the preparation of such a targeting composition including, along with a collagen-binding domain and an intermediate release linker, an alpha-hydroxy acid, and thus, an ordinary skilled artisan would not be motivated to combine Steiner with Nimni, it is found unpersuasive. It is acknowledged that there is not a single reference that teaches and/or suggests a targeting composition of claim 1 when the agent is glycolic acid. However, Applicants are respectfully reminded that the rejection supra is based on obviousness. Pursuant to MPEP 2142, 35 USC 103 authorizes a rejection where, to meet the claim, it is necessary to modify a single reference or to combine it with one or more other references. Since the rejection is based on obviousness, it is unnecessary for every claim limitation to be taught and/or suggested by a single reference. Additionally, 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, as discussed above in the 103 rejection, the combination of Nimni and Steiner is suggestive of the claim limitations as recited in instant claims 1 and 159 when the skin care or cosmeceutical agent is glycolic acid. Nimni expressly claims the instant targeting composition of claim 1 where the targeting composition comprising a therapeutic agent where the therapeutic agent includes skin care or cosmeceutical agents, e.g., a histamine receptor antagonist, a kinin receptor antagonist, or a leukotriene receptor antagonist. Steiner teaches that glycolic acid functions as a therapeutic agent because glycolic acid was known to be the most used alpha hydroxy acid peel, was known to exhibit anti-inflammatory, keratolytic, and antioxidant effects useful to treat acne (inflammatory and non-inflammatory), acne scars, melasma, photoaging, post-inflammatory hyperpigmentation, and skin rejuvenation thereby suggestive of glycolic acid as a therapeutic agent taught by Nimni. As such, the question is (1) whether a person of ordinary skill in the art would be motivated to substitute glycolic acid as the therapeutic agent of Nimni. The Examiner maintains that the answer to this question is yes in light of the teachings of Nimni and Steiner because an ordinary skilled artisan would be motivated to substitute glycolic acid as taught by Steiner as a therapeutic agent of Nimni.
In response to Applicants’ third and fourth arguments, i.e., there is an overall lack of guidance required for an ordinary skilled artisan to combine Steiner and Nimni to result in the claimed invention without requiring undue experimentation, and an ordinary skilled artisan would not have a reasonable expectation of success given the necessity of selecting suitable linkers and collagen-binding domains to provide delivery of the skin care agent or cosmeceutical to the skin in sufficient quantity to produce the desired esthetic result, they are found unpersuasive. Pursuant to MPEP 2143.02(II), obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969). In the instant case, as discussed in the “Response to Arguments” section for the 102 rejection, Nimni’s disclosure anticipates the instant composition of claim 1. As such, there is a presumption that the Nimni disclosure is enabled thereby precluding the need for undue experimentation to make and use the claimed composition. Furthermore, there is no requirement that Nimni reduce-to-practice applying the composition to skin, especially given that the composition does not require such a limitation, and even if the composition is required to be applied to skin topically, such a limitation only imparts structure to the claimed composition by requiring the composition to be in a form capable of application to the skin. Simply because Nimni discloses systemic administration or other forms of administering does not per se render the Nimni disclosure as non-enabled for topical administration to the skin. Similarly, the lack of an expressed teaching of glycolic acid as a therapeutic agent being applied topically to skin in by Nimni or expressed teaching of glycolic acid in the claimed composition by Steiner, which arguably would anticipate instead of render obvious the claimed invention, does not per se result in an ordinary skilled artisan needing undue experimentation or more than a reasonable expectation of success to achieve the claimed invention when the skin care or cosmeceutical agent is glycolic acid. As discussed supra, the question is whether an ordinary skilled artisan would substitute glycolic acid as a therapeutic agent in Nimni’s composition with a reasonable expectation of success. Since Steiner demonstrates that glycolic acid exhibits therapeutic properties, the Examiner maintains that an ordinary skilled artisan would have the requisite expectation of success in achieving the claimed targeting composition when the skin care or cosmeceutical agent is glycolic acid. Thus, contrary to Applicants’ arguments, an ordinary skilled artisan would not undergo undue experimentation or would an ordinary skilled artisan lack the requisite expectation of success in order to achieve the claimed targeting composition when the skin care or cosmeceutical agent is glycolic acid.
In response to Applicant’s fifth argument, i.e., the lead compound analysis renders the claimed invention nonobvious, it is found unpersuasive. The Applicant states, “[w]hen the reasons articulated for modifications of the references are lacking, no prima facie case of obviousness exists” (See Response received 6/11/25, pg. 75). However, as discussed supra, the reasons for modifying Nimni in view of Steiner are not lacking (See discussion supra). Furthermore, Applicant’s argument regarding how the lead compound analysis renders the claimed invention nonobvious is not clear. Pursuant under MPEP 2143(I)(B), the Takeda case brings together the concept of a “lead compound” and the obvious-to-try argument. In Takeda, the court found that there would have been no reason to select a specific compound as a lead compound, especially given that one reference taught certain disadvantageous properties associated with the suggested lead compound. Furthermore, an obvious-to-try rationale would not apply because the prior art disclosed a broad selection of compounds any one of which could have been selected as a lead compound for further investigation. Thus, the MPEP cautions Office personnel that the obvious-to-try rationale does not apply when the appropriate factual findings cannot be made, in particular, when there is no finite number of identified, predictable solutions to the recognized need and no reasonable expectation of success. Here, the Examiner did not utilize a lead compound or obvious-to-try rationale in order to render the claimed invention obvious. Rather, the Examiner utilized some teaching, suggestion or motivation or simple substitution rationale to render the claimed invention obvious. Similarly, neither Nimni or Steiner demonstrate negative properties for glycolic acid or any therapeutic agent that would dissuade an ordinary skilled artisan from substituting glycolic acid as a therapeutic agent. Therefore, contrary to Applicant’s argument, the lead compound analysis is not applicable to whether the claimed invention is obvious over the combination of Nimni and Steiner.
In response to Applicant’s sixth argument, i.e., the In re Opprecht and In re Bode decisions cited in the 103 rejection introduction do not support the rejection, it is found unpersuasive. It is noted that the rejection includes both cases in the introduction. However, neither case was relied upon to render the claimed invention obvious. Rather, KSR was relied upon to render the claimed invention obvious. However, it is noted that Nimni teaches specific embodiments of therapeutic agents that also function as skin care or cosmeceutical agents (See discussion in the 102 rejection supra). Therefore, contrary to Applicant’s argument, the substitution of one therapeutic agent, e.g., histamine receptor antagonist, for another therapeutic agent, glycolic acid, would be simple without requiring orders of magnitude of complexity.
Accordingly, the rejection of claims 1 and 159 is maintained as Applicants’ arguments are found unpersuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
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, Lianko Garyu can be reached on 571-270-7367. 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.
/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
